Trial Outcomes & Findings for Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors (NCT NCT03615105)
NCT ID: NCT03615105
Last Updated: 2025-04-06
Results Overview
The intervention will be considered unpromising if the rate of GVHD is greater than 40% and promising if the rate is 20% or less. Number of participants with and without SAE will be evaluated.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
2 years
Results posted on
2025-04-06
Participant Flow
Participant milestones
| Measure |
Radiation, Thiotepa & Cyclophosphamide
Hyperfractionated total body irradiation: Hyperfractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1,375 or 1,500 cGy) over 4 days (days -9 through -6).
Thiotepa: Thiotepa 5 mg/kg IV
Cyclophosphamide: Cyclophosphamide 60 mg/kg IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
Busulfan, Fludarabine & Melphalan
Busulfan: Busulfan (adult/ped dose)
Fludarabine: Fludarabine 25 mg/m2 IV
Melphalan: Melphalan 70 mg/m2 IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
Clofarabine, Thiotepa & Melphalan
Thiotepa: Thiotepa 5 mg/kg IV
Melphalan: Melphalan 70 mg/m2 IV
Clofarabine: Clofarabine 20-30 mg/m2 IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
1
|
|
Overall Study
COMPLETED
|
2
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Radiation, Thiotepa & Cyclophosphamide
Hyperfractionated total body irradiation: Hyperfractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1,375 or 1,500 cGy) over 4 days (days -9 through -6).
Thiotepa: Thiotepa 5 mg/kg IV
Cyclophosphamide: Cyclophosphamide 60 mg/kg IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
Busulfan, Fludarabine & Melphalan
Busulfan: Busulfan (adult/ped dose)
Fludarabine: Fludarabine 25 mg/m2 IV
Melphalan: Melphalan 70 mg/m2 IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
Clofarabine, Thiotepa & Melphalan
Thiotepa: Thiotepa 5 mg/kg IV
Melphalan: Melphalan 70 mg/m2 IV
Clofarabine: Clofarabine 20-30 mg/m2 IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
2
|
0
|
Baseline Characteristics
Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors
Baseline characteristics by cohort
| Measure |
Radiation, Thiotepa & Cyclophosphamide
n=3 Participants
Hyperfractionated total body irradiation: Hyperfractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1,375 or 1,500 cGy) over 4 days (days -9 through -6).
Thiotepa: Thiotepa 5 mg/kg IV
Cyclophosphamide: Cyclophosphamide 60 mg/kg IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
Busulfan, Fludarabine & Melphalan
n=5 Participants
Busulfan: Busulfan (adult/ped dose)
Fludarabine: Fludarabine 25 mg/m2 IV
Melphalan: Melphalan 70 mg/m2 IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
Clofarabine, Thiotepa & Melphalan
n=1 Participants
Thiotepa: Thiotepa 5 mg/kg IV
Melphalan: Melphalan 70 mg/m2 IV
Clofarabine: Clofarabine 20-30 mg/m2 IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20 years
n=99 Participants
|
31 years
n=107 Participants
|
23 years
n=206 Participants
|
26 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe intervention will be considered unpromising if the rate of GVHD is greater than 40% and promising if the rate is 20% or less. Number of participants with and without SAE will be evaluated.
Outcome measures
| Measure |
Radiation, Thiotepa & Cyclophosphamide
n=3 Participants
Hyperfractionated total body irradiation: Hyperfractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1,375 or 1,500 cGy) over 4 days (days -9 through -6).
Thiotepa: Thiotepa 5 mg/kg IV
Cyclophosphamide: Cyclophosphamide 60 mg/kg IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
Busulfan, Fludarabine & Melphalan
n=5 Participants
Busulfan: Busulfan (adult/ped dose)
Fludarabine: Fludarabine 25 mg/m2 IV
Melphalan: Melphalan 70 mg/m2 IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
Clofarabine, Thiotepa & Melphalan
n=1 Participants
Thiotepa: Thiotepa 5 mg/kg IV
Melphalan: Melphalan 70 mg/m2 IV
Clofarabine: Clofarabine 20-30 mg/m2 IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
|---|---|---|---|
|
the Number of Incidences of Grade 3-4 Acute GVHD
Number of participants with SAE
|
2 Participants
|
3 Participants
|
1 Participants
|
|
the Number of Incidences of Grade 3-4 Acute GVHD
Number of participants without SAE
|
1 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Radiation, Thiotepa & Cyclophosphamide
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Busulfan, Fludarabine & Melphalan
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Clofarabine, Thiotepa & Melphalan
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Radiation, Thiotepa & Cyclophosphamide
n=3 participants at risk
Hyperfractionated total body irradiation: Hyperfractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1,375 or 1,500 cGy) over 4 days (days -9 through -6).
Thiotepa: Thiotepa 5 mg/kg IV
Cyclophosphamide: Cyclophosphamide 60 mg/kg IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
Busulfan, Fludarabine & Melphalan
n=5 participants at risk
Busulfan: Busulfan (adult/ped dose)
Fludarabine: Fludarabine 25 mg/m2 IV
Melphalan: Melphalan 70 mg/m2 IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
Clofarabine, Thiotepa & Melphalan
n=1 participants at risk
Thiotepa: Thiotepa 5 mg/kg IV
Melphalan: Melphalan 70 mg/m2 IV
Clofarabine: Clofarabine 20-30 mg/m2 IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
33.3%
1/3 • 2 years
|
20.0%
1/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders, other
|
33.3%
1/3 • 2 years
|
0.00%
0/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • 2 years
|
0.00%
0/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Cardiac disorders
Sinus Tachycardia
|
33.3%
1/3 • 2 years
|
0.00%
0/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
33.3%
1/3 • 2 years
|
0.00%
0/5 • 2 years
|
100.0%
1/1 • 2 years
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • 2 years
|
0.00%
0/5 • 2 years
|
100.0%
1/1 • 2 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • 2 years
|
20.0%
1/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 2 years
|
40.0%
2/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/3 • 2 years
|
40.0%
2/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • 2 years
|
20.0%
1/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/3 • 2 years
|
20.0%
1/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Infections and infestations
Lung Infection
|
0.00%
0/3 • 2 years
|
20.0%
1/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • 2 years
|
0.00%
0/5 • 2 years
|
100.0%
1/1 • 2 years
|
|
Infections and infestations
Infection and infestations, other
|
0.00%
0/3 • 2 years
|
0.00%
0/5 • 2 years
|
100.0%
1/1 • 2 years
|
Other adverse events
| Measure |
Radiation, Thiotepa & Cyclophosphamide
n=3 participants at risk
Hyperfractionated total body irradiation: Hyperfractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1,375 or 1,500 cGy) over 4 days (days -9 through -6).
Thiotepa: Thiotepa 5 mg/kg IV
Cyclophosphamide: Cyclophosphamide 60 mg/kg IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
Busulfan, Fludarabine & Melphalan
n=5 participants at risk
Busulfan: Busulfan (adult/ped dose)
Fludarabine: Fludarabine 25 mg/m2 IV
Melphalan: Melphalan 70 mg/m2 IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
Clofarabine, Thiotepa & Melphalan
n=1 participants at risk
Thiotepa: Thiotepa 5 mg/kg IV
Melphalan: Melphalan 70 mg/m2 IV
Clofarabine: Clofarabine 20-30 mg/m2 IV
HPC(A) stem cell allograft: All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
Rituximab: Rituximab 200 mg IV flat dose
Rabbit antithymocyte globulin: Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 2 years
|
20.0%
1/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 2 years
|
40.0%
2/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • 2 years
|
20.0%
1/5 • 2 years
|
100.0%
1/1 • 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • 2 years
|
40.0%
2/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
33.3%
1/3 • 2 years
|
0.00%
0/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 2 years
|
20.0%
1/5 • 2 years
|
100.0%
1/1 • 2 years
|
|
Investigations
Lipase increased
|
0.00%
0/3 • 2 years
|
20.0%
1/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • 2 years
|
100.0%
5/5 • 2 years
|
100.0%
1/1 • 2 years
|
|
Investigations
Serum amylase increased
|
0.00%
0/3 • 2 years
|
20.0%
1/5 • 2 years
|
0.00%
0/1 • 2 years
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • 2 years
|
100.0%
5/5 • 2 years
|
100.0%
1/1 • 2 years
|
Additional Information
Dr. Brian Shaffer, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3737
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place