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Anti-metabolites

Intensity Modulated Total Marrow Irradiation + Fludarabine Phosphate + Melphalan for Hematologic Cancers

Phase 1

Recruiting

Led By Hongtao Liu

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Karnofsky performance status of 70 or above

No evidence of chronic active hepatitis or cirrhosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing IMTMI to see if it's less toxic and more effective than other types of radiation therapy when given with fludarabine and melphalan to patients with relapsed blood cancer before a stem cell transplant.

Who is the study for?

This trial is for patients with relapsed blood cancers like AML or high-risk MDS, who are undergoing a second stem cell transplant. They should have good kidney and liver function, not be pregnant, HIV-negative, and have a Karnofsky performance status of 70+. The donor can be the same as the first transplant or a different matched donor.Check my eligibility

What is being tested?

The trial tests intensity modulated total marrow irradiation (IMTMI) combined with fludarabine phosphate and melphalan before a second stem cell transplant. It aims to see how well this approach works in stopping cancer growth and preventing immune rejection of the new stem cells.See study design

What are the potential side effects?

Potential side effects include damage to normal bone marrow cells leading to low blood counts, increased risk of infections due to immune system suppression, organ inflammation from radiation therapy, nausea from chemotherapy drugs, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself but cannot carry on normal activity or do active work.

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I do not have chronic hepatitis or cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

MTD of conditioning regimen defined as any grade III or higher dose-limiting toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Secondary outcome measures

Overall incidence of adverse events, graded according to the NCI CTCAE version 4.0

Time to neutrophil engraftment

Time to platelet engraftment

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (IMTMI, combination chemotherapy, PBSCT or BMT)Experimental Treatment10 Interventions

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes daily on days -7 to -3 and melphalan IV on day -2. Patients also undergo IMTMI BID for 2 to 5 days between days -7 to -3. TRANSPLANT: Patients undergo allogeneic PBSCT or BMT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO BID on days -2 to 180 with taper thereafter and mycophenolate mofetil IV every 8 hours or PO on days 0-28 (for matched donors) or days 0-40 (for alternative donors) with taper to day 60.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allogeneic Bone Marrow Transplantation

2009

Completed Phase 2

~470

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1200

Total Marrow Irradiation

2014

Completed Phase 1

~20

Fludarabine Phosphate

1997

Completed Phase 3

~2390

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

Tacrolimus

2011

Completed Phase 4

~4740

Melphalan

2008

Completed Phase 3

~1500

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,747 Total Patients Enrolled

4 Trials studying Myelodysplastic Syndromes (MDS)

140 Patients Enrolled for Myelodysplastic Syndromes (MDS)

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,824 Total Patients Enrolled

116 Trials studying Myelodysplastic Syndromes (MDS)

30,493 Patients Enrolled for Myelodysplastic Syndromes (MDS)

Hongtao LiuPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center

5 Previous Clinical Trials

203 Total Patients Enrolled

1 Trials studying Myelodysplastic Syndromes (MDS)

12 Patients Enrolled for Myelodysplastic Syndromes (MDS)

Media Library

Fludarabine Phosphate (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02333162 — Phase 1

Myelodysplastic Syndromes (MDS) Research Study Groups: Treatment (IMTMI, combination chemotherapy, PBSCT or BMT)

Myelodysplastic Syndromes (MDS) Clinical Trial 2023: Fludarabine Phosphate Highlights & Side Effects. Trial Name: NCT02333162 — Phase 1

Fludarabine Phosphate (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02333162 — Phase 1

Frequently Asked Questions

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

Are there any short- or long-term risks associated with Allogeneic Hematopoietic Stem Cell Transplantation?

"Due to the limited safety and efficacy data present, our team at Power has assigned Allogeneic Hematopoietic Stem Cell Transplantation a rating of 1."

Answered by AI

What is the enrollment size of this clinical trial?

"Affirmative, information posted on clinicaltrials.gov states that this medical trial is actively sourcing participants. Initially launching on December 5th 2014 and updated as recently at January 7th 2022, the study seeks to recruit 30 patients from a single site."

Answered by AI

What are the criteria for joining this research study?

"In order to be eligible for this trial, participants must have acute myelocytic leukemia and lie within the age range of 18-75. The study is seeking roughly 30 individuals."

Answered by AI

What medical conditions benefit from Allogeneic Hematopoietic Stem Cell Transplantation?

"Allogeneic Hematopoietic Stem Cell Transplantation is frequently used to treat dermatitis, atopic. It may also be beneficial in the management of rejection; transplant, liver, rejection; transplant, kidney and psoriasis ailments."

Answered by AI

Are there any enrollment opportunities at present for this research project?

"Data from clinicaltrials.gov attests that this trial is actively seeking new participants, with the initial posting on December 5th 2014 and its most recent update being January 7th 2022."

Answered by AI

Does this research encompass geriatric patients?

"To qualify for this experiment, potential participants must be between 18 and 75 years old. Additionally, there are 1078 trials available to those under 18 years of age and 4728 options exist for patients over 65."

Answered by AI

Could you please provide an overview of other experiments involving Allogeneic Hematopoietic Stem Cell Transplantation?

"Currently, there are 574 trials ongoing for Allogeneic Hematopoietic Stem Cell Transplantation. Out of these studies, 62 have progressed to Stage 3. Philadelphia is the epicentre of research in this field; however, it can be accessed at 6491 sites across the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant

2014. "Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02333162.

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