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Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML

NCT04002115 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-09-14

Study results available
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Summary

The Investigators would like to study the incidence of complete remission (CR) at day +30 after Clofarabine followed by haploidentical transplant. The conditioning regimen used is Fludarabine, Busulfan (2 doses) or cyclophosphamide (2 doses) and Total Body Irradiation (TBI) with post transplant cyclophosphamide for patients with Acute Myeloid Leukemia (AML) who are not in remission prior to considering allogeneic transplant with haploidentical donors.

Conditions

Interventions

DRUG

Clofarabine

Clofarabine to be administered pre-stem cell transplant infusion ("Day 0") once a day for 5 days total.

DRUG

Fludarabine

Fludarabine will be administered once a day for 4 days as part of the transplant conditioning regimen.

DRUG

Busulfan

Busulfan will be administered once a day for 2 days as part of the transplant conditioning regimen.

PROCEDURE

Total Body Irradiation (TBI)

TBI will be administered at a dose of 200cGys on Day -1 prior to transplant

DRUG

Cyclophosphamide

Cyclophosphamide will be given once a day for 2 days after the transplant infusion.

DRUG

Granulocyte Colony-Stimulating Factor

G-CSF will be administered to subjects starting on Day +5 and will continue as clinically indicated

DRUG

Tacrolimus

Tacrolimus will be administered to subjects starting on Day +5 and will continue as clinically indicated

DRUG

Cellcept

Mycophenolate Mofetil will be administered to subjects starting on Day +5 and will continue as clinically indicated

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Seema Naik, MD · Penn State Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-03
Primary Completion
2022-08-30
Completion
2022-11-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT04002115 on ClinicalTrials.gov