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T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia

NCT03531736 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-08-19

No results posted yet for this study

Summary

The main purpose of this study is to learn if a new combination of chemotherapy, in combination with low-dose radiation, will be safe for the patient, and at the same time provide the best opportunity to cure the bone marrow cancer. The combination of chemotherapy and radiation described in the study is considered 'low intensity.' Although the chemotherapy agents used in this study and for transplant are FDA approved, the chemotherapy treatment and conditioning regimens or combinations listed in this consent are not yet FDA approved.

The CliniMACS device is FDA approved for one type of T cell depletion (positive selection of the stem cells) but not approved yet for other type of T cell depletion, which is being studied on this protocol. This pilot study, along with other studies will serve as the basis for FDA approval, if outcomes are favorable.

Conditions

  • Myeloid Diseases

Interventions

DRUG

Antithymocyte globulin (Rabbit)

ATG (2 mg/kg/d IV on days-8 through -7)

DRUG

fludarabine

fludarabine (30 mg/m2/d on days -5 through -2)

RADIATION

total body irradiation

TBI 200 cGy (days -2 and -1) given post stem cell infusion

DRUG

cyclophosphamide

cyclophosphamide given post stem cell infusion (50 mg/kg on days +3 and +4)

DRUG

Rituxan

Rituxan (200 mg/m2) will be given to reduce the risk of EBV viremia

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Allogeneic Hematopoietic Stem Cell Transplantation

Sponsors & Collaborators

Principal Investigators

  • Roni Tamari, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03531736 on ClinicalTrials.gov