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Anti-metabolites

Chemotherapy + Stem Cell Transplant for Leukemia

Phase 2

Waitlist Available

Research Sponsored by Herbert Irving Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Genetic disorder including storage disease (e.g., adrenoleukodystrophy), hemoglobinopathies (e.g., thalassemia), or severe immunodeficiency, and unwillingness to undergo conventional high-dose chemoradiotherapeutic conditioning prior to allogeneic stem cell transplantation OR presence of other medical disorder which precludes high-dose chemoradiotherapeutic conditioning (e.g., cardiac disease or infection)

Acute myeloid leukemia, acute lymphocytic leukemia, myelodysplasia, or lymphoma with high risk of relapse or progressive disease and typical clinical features and morphology in blood, marrow, lymph node, or other tissue by cytochemistry, immunophenotyping, and/or chromosomal abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is giving chemotherapy to patients before a donor bone marrow or peripheral blood stem cell transplant to help stop the patient's immune system from rejecting the donor's stem cells.

Who is the study for?

This trial is for patients aged 1-80 with certain blood cancers or genetic disorders, who have a suitable donor for bone marrow or stem cell transplant. They must not be pregnant, nursing, or have serious illnesses that could interfere with the study. Patients outside the US or with other recent cancers are excluded.Check my eligibility

What is being tested?

The trial tests if chemotherapy (fludarabine and melphalan) followed by a transplant from a donor's bone marrow or peripheral blood stem cells can treat hematologic cancer or genetic disorders effectively by replacing diseased cells with healthy ones.See study design

What are the potential side effects?

Possible side effects include immune system reactions against the new stem cells, infection risks due to weakened immunity post-transplant, potential organ damage from chemotherapy drugs, and general symptoms like fatigue and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a genetic disorder or a medical condition that prevents me from undergoing intense chemotherapy or radiation before a stem cell transplant.

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I have a high-risk blood cancer with specific test results.

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I have a blood cancer or genetic disorder confirmed by tests.

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I can perform most of my daily activities without assistance.

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I have multiple myeloma with specific bone marrow and blood protein findings.

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I have chronic myelogenous leukemia with specific blood/marrow features or genetic markers.

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I have been diagnosed with aplastic anemia.

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My donor is a perfect match or nearly matches me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hematopoietic recovery

Incidence of graft-versus-host disease

Secondary outcome measures

Chemotherapeutic toxicity

Relapse and survival

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,101 Total Patients Enrolled

1,512 Trials studying Leukemia

384,630 Patients Enrolled for Leukemia

Herbert Irving Comprehensive Cancer CenterLead Sponsor

33 Previous Clinical Trials

877 Total Patients Enrolled

4 Trials studying Leukemia

100 Patients Enrolled for Leukemia

David G. Savage, MDStudy ChairHerbert Irving Comprehensive Cancer Center

3 Previous Clinical Trials

108 Total Patients Enrolled

2 Trials studying Leukemia

78 Patients Enrolled for Leukemia

Media Library

Fludarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00008307 — Phase 2

Leukemia Clinical Trial 2023: Fludarabine Highlights & Side Effects. Trial Name: NCT00008307 — Phase 2

Fludarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00008307 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to partake in this experiment?

"This clinical trial is looking to enrol 52 participants, who must be between 1 year old and 80 years of age, and diagnosed with leukemia."

Answered by AI

Is the minimum age requirement for this experiment set at 18?

"The requirements of this medical trial necessitate that participants are between one year old and eighty years old. There exist 964 clinical trials for individuals under 18, or 4020 studies for those above the age of 65."

Answered by AI

Is enrollment open for the current trial?

"According to the clinicaltrials.gov database, recruitment for this trial has been suspended since January 3rd 2014 and as such is not open to applicants anymore. Though no longer recruiting, there are still 4781 medical experiments that require participants at this time."

Answered by AI

Has this course of therapy been given the green light by the FDA?

"Available data indicates that this experimental treatment holds a safety rating of 2. This is due to the fact it has passed Phase 2 trials, meaning there are preliminary insights into its potential hazards but no evidence yet showing efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Chemotherapy Followed by Donor Bone Marrow Transplant or Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer or Genetic Disorders

1998. "Combination Chemotherapy Followed by Donor Bone Marrow Transplant or Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer or Genetic Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00008307.

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