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Allogeneic Stem Cell Transplant for CLL

NCT01629511 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-02-24

Study results available
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Summary

This phase I/II trial studies the best dose and side effects of gemcitabine and how well it works with clofarabine and busulfan and donor stem cell transplant in treating participants with chronic lymphocytic leukemia. Drugs used in chemotherapy, such as gemcitabine, clofarabine, and busulfan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

Conditions

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo stem cell transplant

BIOLOGICAL

Anti-Thymocyte Globulin

Given IV

DRUG

Busulfan

Given IV

DRUG

Clofarabine

Given IV

BIOLOGICAL

Filgrastim

Given SC

DRUG

Gemcitabine

Given IV

DRUG

Methotrexate

Given IV

DRUG

Tacrolimus

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Chitra Hosing · M.D. Anderson Cancer Center

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-21
Primary Completion
2018-04-25
Completion
2018-04-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01629511 on ClinicalTrials.gov