Allo HSCT Using RIC and PTCy for Hematological Diseases

Summary

This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.

Conditions

• Acute Myelogenous Leukemia
• Acute Lymphocytic Leukemia
• Biphenotypic Acute Leukemia
• Undifferentiated Leukemia
• Prolymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Plasma Cell Leukemia
• Myelodysplastic Syndromes
• Leukemia, Myeloid
• Myelodysplastic Syndrome With Excess Blasts-1
• Burkitt Lymphoma
• Relapsed T-Cell Lymphoma
• Relapsed Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma
• Marginal Zone Lymphoma
• Follicular Lymphoma
• Myeloproliferative Neoplasm
• Myelofibrosis

Interventions

BIOLOGICAL

Peripheral Blood Stem Cell Transplant

On day 0, a target dose of 5 x 106 CD34 cells/kg will be infused.

DRUG

Allopurinol 300 MG

300 mg/day from day -7 to day 0. Allopurinol 150mg/m2/day for pediatric participants.

DRUG

Fludarabine

30 mg/m2 IV over 1 hour. Administered on day -6 to day -2.

DRUG

Cyclophosphamide

Administered as a 2 hour IV infusion on day -6, +3, and +4.

BIOLOGICAL

Bone Marrow Cell Transplant

On day 0, a target dose of 3 x 108 nucleated cells/kg recipient weight will be infused.

RADIATION

Total Body Irradiation

The dose of TBI will be 200 cGy given in a single fraction on day -1.

DRUG

Sirolimus Pill

All participants begin +5 to day +60. Loading dose on day +5 of 5 mg/m2/day orally once (max dose of 8 mg). Maintenance dose 2.5 mg/m2 orally daily to maintain a level of 8-12 ng/ml (max dose of 4 mg).

DRUG

Mycophenolate Mofetil

All patients begin day +5 through day +35. 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 doses. In obese patients (\>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patients will receive MMF at the dose of 15 mg/kg/dose (maximum of 1 gram per dose) every 8 hours.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota

  lead OTHER

Principal Investigators

• Mark Juckett · University of Minnesota Masonic Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-01

Primary Completion

2027-10-22

Completion

2028-10-22

FDA Drug

Yes

Countries

• United States

Study Locations