Trial Outcomes & Findings for Imatinib Mesylate, Busulfan, Fludarabine, and Antithymocyte Globulin for CML Patients (NCT NCT00499889)
NCT ID: NCT00499889
Last Updated: 2012-04-23
Results Overview
Participants at 1 year in molecular remission, post transplant, post imatinib mesylate and donor lymphocyte infusion (DLI). Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests (this test is most commonly used in clinical trials).
TERMINATED
PHASE2
42 participants
Baseline to 1 year
2012-04-23
Participant Flow
Recruitment Period: 02/12/03 to 01/15/09. All patients were recruited at UT MD Anderson Cancer Center.
One patient registered for transplant became ineligible before any treatment due to infection and was taken off study; 41 patients received the transplant regimen and an Allogeneic transplant.
Participant milestones
| Measure |
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin
Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m\^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m\^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin
Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m\^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m\^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
|
|---|---|
|
Overall Study
Infection prior to treatment
|
1
|
Baseline Characteristics
Imatinib Mesylate, Busulfan, Fludarabine, and Antithymocyte Globulin for CML Patients
Baseline characteristics by cohort
| Measure |
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin
n=42 Participants
Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m\^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m\^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Age Continuous
|
42.2 years
FULL_RANGE 42 • n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1 yearPopulation: Analysis was per protocol. One patient did not receive treatment and was excluded from analysis.
Participants at 1 year in molecular remission, post transplant, post imatinib mesylate and donor lymphocyte infusion (DLI). Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests (this test is most commonly used in clinical trials).
Outcome measures
| Measure |
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin
n=41 Participants
Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m\^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m\^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
|
|---|---|
|
Number of Participants in Complete Molecular Remission at 1 Year
|
21 participants
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Analysis was per protocol. Only 19 participants having the post transplant Imatinib Mesylate Therapy out of the 41 participants treated were analyzed for this outcome.
Number of participants with response of molecular complete remission (mCR) to Imatinib Mesylate therapy as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests.
Outcome measures
| Measure |
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin
n=19 Participants
Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m\^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m\^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
|
|---|---|
|
Participants' With mCR Response to Post Transplant Imatinib Mesylate Therapy
|
10 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Only 8 participants having the post-transplant DLI out of the 41 participants treated were analyzed for this outcome.
Number of participants with response of molecular complete remission (mCR) to DLI as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests.
Outcome measures
| Measure |
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin
n=8 Participants
Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m\^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m\^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
|
|---|---|
|
Participants' With mCR Response to Post Transplant DLI
|
4 Participants
|
Adverse Events
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin
Serious adverse events
| Measure |
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin
n=41 participants at risk
Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m\^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m\^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
|
|---|---|
|
Blood and lymphatic system disorders
severe anemia
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Hepatobiliary disorders
increased bilirubin
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Infections and infestations
Neutropenic Fever
|
4.9%
2/41 • Number of events 2 • 5 years and 6 months
|
|
Nervous system disorders
neurologic
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Gastrointestinal disorders
Abdominal Distention
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Cardiac disorders
Hypertensive Crisis
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Blood and lymphatic system disorders
Myelosupression
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Immune system disorders
GVHD
|
4.9%
2/41 • Number of events 2 • 5 years and 6 months
|
Other adverse events
| Measure |
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin
n=41 participants at risk
Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m\^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m\^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
|
|---|---|
|
Hepatobiliary disorders
increased LDH
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Infections and infestations
infection
|
14.6%
6/41 • Number of events 6 • 5 years and 6 months
|
|
Infections and infestations
decreased neutrpoenia
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Nervous system disorders
neurolgic other
|
4.9%
2/41 • Number of events 2 • 5 years and 6 months
|
|
Nervous system disorders
headache
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Nervous system disorders
drowiness
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Skin and subcutaneous tissue disorders
skin other
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Skin and subcutaneous tissue disorders
skin rash
|
12.2%
5/41 • Number of events 5 • 5 years and 6 months
|
|
Blood and lymphatic system disorders
Granulocytes
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Blood and lymphatic system disorders
platelets
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Cardiac disorders
increased blood pressure
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Blood and lymphatic system disorders
increased prothrombin time
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Infections and infestations
fever
|
9.8%
4/41 • Number of events 4 • 5 years and 6 months
|
|
General disorders
fatigue
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Gastrointestinal disorders
Gastrointestional Disorder (other)
|
4.9%
2/41 • Number of events 2 • 5 years and 6 months
|
|
Gastrointestinal disorders
esophagitis
|
9.8%
4/41 • Number of events 4 • 5 years and 6 months
|
|
Gastrointestinal disorders
nausea
|
9.8%
4/41 • Number of events 4 • 5 years and 6 months
|
|
Gastrointestinal disorders
diarrhea
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
|
Hepatobiliary disorders
increased alanine aminotransferase (ALT)
|
2.4%
1/41 • Number of events 1 • 5 years and 6 months
|
Additional Information
Richard E. Champlin, MD/Professor
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place