Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Hematologic Cancer

NCT ID: NCT00004114

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced hematologic cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES: I. Determine the feasibility of allogeneic engraftment after unrelated matched allogeneic peripheral blood stem cell transplantation preceded by a nonmyeloablative, fludarabine based conditioning regimen in patients with advanced hematologic malignancies. II. Determine the toxicities of this regimen, especially graft versus host disease, in these patients.

OUTLINE: Patients receive fludarabine IV over 30-60 minutes on days -7 to -4, cyclophosphamide IV over 30 minutes on days -7 to -5, and cytarabine IV over 2 hours on days -4 and -3. Allogeneic peripheral blood stem cells are infused on day 0. Filgrastim (G-CSF) is administered IV over 1 hour or subcutaneously beginning on day 1 and continuing until blood counts recover. Patients are followed weekly until day 60 and then monthly for 10 months.

PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukemia Lymphoma Myelodysplastic Syndromes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

filgrastim

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

cytarabine

Intervention Type DRUG

fludarabine phosphate

Intervention Type DRUG

peripheral blood stem cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

PATIENT CHARACTERISTICS: Age: See Disease Characteristics Adult Performance status: See Disease Characteristics Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics SGOT/SGPT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: See Disease Characteristics Pulmonary: DLCO at least 50% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christos E. Emmanouilides, MD

Role: STUDY_CHAIR

Jonsson Comprehensive Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UCLA-9902026

Identifier Type: -

Identifier Source: secondary_id

NCI-G99-1603

Identifier Type: -

Identifier Source: secondary_id

CDR0000067340

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.