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Alkylating Agent

Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide for Acute Leukemia (1703/1801 Trial)

Phase 3
Waitlist Available
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post-transplant
Awards & highlights

1703/1801 Trial Summary

This trial is comparing two ways to prevent GVHD, a complication of stem cell transplants. One group will receive tacrolimus/methotrexate and the other group will receive post-transplant cyclophosphamide/tacrolimus/mycophenolate mofetil. The trial will also test the hypothesis that the engraftment stool microbiome diversity predicts one-year non-relapse mortality.

Eligible Conditions
  • Acute Leukemia
  • Leukemia
  • Myelodysplasia
  • Lymphoma

1703/1801 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With GVHD/Relapse or Progression-free Survival (GRFS) at One Year
Secondary outcome measures
Frequencies of Infections Categorized by Infection Type
Number of Participants Experiencing Chronic GVHD With Maximum Severity at 12 Months Post-transplant
Number of Participants Reporting Grade 3-5 Toxicities by 1 Year Post-transplant
+20 more

Side effects data

From 2022 Phase 3 trial • 431 Patients • NCT03959241
34%
Grades 3-5 Cardiac Disorders
27%
Grades 3-5 GI Disorders
25%
Grades 3-5 General Disorders
20%
Grades 3-5 Respiratory, Thoracic and Mediastinal Disorders
16%
Grades 3-5 Renal Disorders
12%
Grades 3-5 Hepatic Disorders
12%
Grades 3-5 Metabolism and Nutrition Disorders
8%
Grades 3-5 Musculoskeletal and Connective Tissue Disorders
7%
Abnormal liver function
6%
Grades 3-5 Nervous System Disorders
6%
Grades 3-5 Hemorrhagic Disorders
5%
Received Dialysis
3%
Hepatitis
3%
Grades 3-5 Vascular Disorders
2%
Grades 3-5 Immune System Disorders
1%
Liver failure
1%
Grades 3-5 Blood and Lymphatic Disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
PTCY/Tacrolimus/MMF
Tacrolimus/Methotrexate

1703/1801 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tacrolimus/MMF/PTCYExperimental Treatment4 Interventions
Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide
Group II: Tacrolimus/MethotrexateActive Control3 Interventions
Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Methotrexate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Tacrolimus
2011
Completed Phase 4
~4740
Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide
2019
Completed Phase 3
~440

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
604 Previous Clinical Trials
1,161,825 Total Patients Enrolled
Blood and Marrow Transplant Clinical Trials NetworkNETWORK
49 Previous Clinical Trials
13,551 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,215 Total Patients Enrolled

Frequently Asked Questions

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

Is this trial being run in a considerable number of hospitals throughout the nation?

"Currently, there are 39 different sites recruiting patients for this study. The locations of these centres include Cleveland, Seattle and Charleston. To reduce the amount of travelling required, it is best to choose a location near you."

Answered by AI

How many individuals are taking part in this experiment?

"This study is not enrolling new patients at this time. The trial was first posted on June 25th, 2019 and last updated on November 10th, 20202. There are currently 3088 other trials actively recruiting participants with myelodysplasia and 1109 trials for Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide that are also looking for candidates."

Answered by AI

Does the FDA sanction using Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide?

"This Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide has received a 3 for safety. This is due to the fact that it is a Phase 3 trial, and thus there is some evidence of efficacy as well as multiple rounds of data affirming its safety."

Answered by AI

Are there other ongoing medical trials that are using a similar treatment to MPBSTC with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide?

"The first study investigating the use of Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide was conducted in 1997 at City of Hope Comprehensive Cancer Center. Since that time, there have been 2126 completed studies and 1109 active clinical trials worldwide--many of which are enrolling patients in Cleveland, Ohio."

Answered by AI

How can people sign up for this research opportunity?

"Unfortunately, this study is no longer seeking new patients. The trial was first posted on June 25th, 2019 and last updated on November 10th, 2022. However, there are 3088 other studies actively recruiting patients with myelodysplasia and 1109 trials for Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide that may be of interest."

Answered by AI

What is the standard procedure for Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide?

"Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide can be used to treat small cell lung cancer (sclc), dermatitis, atopic, and multiple sclerosis."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
~75 spots leftby Mar 2025