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Giving Chemotherapy for a Shortened Amount of Time Before a Stem Cell Transplantation

NCT04098393 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-06-29

No results posted yet for this study

Summary

The purpose of this study is to see if a condensed version of the chemotherapy regimen busulfan, melphalan, fludarabine (bu/mel/flu) and the drug antithymocyte globulin (ATG-also referred to as rATG or thymoglobulin) can have the same or fewer number of severe side effects in people with various blood cancers 30 days after they receive an allogeneic hematopoietic cell transplantation.

Conditions

Interventions

DRUG

Busulfan 3.2 mg/kg/day

Busulfan 3.2 mg/kg/day, with dose adjustments made according to pharmacokinetic (PK) levels.

DRUG

Fludarabine

Fludarabine (25mg/m2/ day) administered on days -6, -5, -4, -3, and -2.

DRUG

Melphalan

Melphalan (70mg/m2/day) administered on days -6 and -5.

DRUG

Antithymocyte globulin (ATG)

ATG will be given based on a dynamic nomogram based on the patient's absolute lymphocyte count at the start of conditioning and can result in 2 or 3 days of ATG administration.

DRUG

Busulfan 0.8 mg/kg

Busulfan 0.8 mg/kg every 6 hours x 10 doses, with dose adjustments made according to PK levels.

PROCEDURE

Allogeneic hematopoietic cell transplantation (Allo-HCT)

Allogeneic hematopoietic cell transplantation following the conditioning regimen.

Sponsors & Collaborators

Principal Investigators

  • Michael Scordo, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-18
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT04098393 on ClinicalTrials.gov