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Tacrolimus + MMF for Blood Cancer

Phase 2
Waitlist Available
Led By Peter A McSweeney, MD
Research Sponsored by Colorado Blood Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients of any age with hematologic malignancies treatable by allogeneic SCT, who, because of pre-existing medical conditions, are considered to be at significantly increased risk for transplant toxicity using high-dose transplant regimens
Patients aged < 70 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new way to give a bone marrow transplant that may be safer with fewer side effects.

Who is the study for?
This trial is for patients with various hematological malignancies who have relapsed after prior treatments or are at high risk of relapse. It's also open to those with specific cancers and comorbidities that make them unsuitable for intense transplant regimens, including older adults or those with pre-existing conditions. Participants must have a matched sibling donor, be under 70 years old, and agree to use contraception.Check my eligibility
What is being tested?
The study tests whether a non-myeloablative allogeneic stem cell transplant (SCT) from a matched sibling donor using fludarabine and low-dose TBI can safely establish stable grafting in patients. It also examines the incidence of moderate to severe GVHD when tacrolimus and MMF are used as post-grafting immunosuppression.See study design
What are the potential side effects?
Possible side effects include complications related to immune suppression such as increased infection risk, organ inflammation due to GVHD where the body might attack the new cells, reactions related to medication like tacrolimus and MMF which could affect kidney function, blood pressure, or cause gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a blood cancer treatable by stem cell transplant but am at high risk for transplant side effects due to other health issues.
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I am younger than 70 years old.
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My blood cancer has returned after a stem cell transplant using my own cells.
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I have CLL or low-grade NHL and my first treatment didn't work.
Select...
I have a family member who is a perfect match for a bone marrow transplant.

Timeline

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
The main endpoints are day 100 mortality and acute GVHD.

Find a Location

Who is running the clinical trial?

Colorado Blood Cancer InstituteLead Sponsor
3 Previous Clinical Trials
90 Total Patients Enrolled
Peter A McSweeney, MDPrincipal InvestigatorColorado Blood Cancer Institute

Media Library

Treatment Clinical Trial Eligibility Overview. Trial Name: NCT00304720 — Phase 2
Lymphoma Research Study Groups:
Lymphoma Clinical Trial 2023: Treatment Highlights & Side Effects. Trial Name: NCT00304720 — Phase 2
Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT00304720 — Phase 2

Frequently Asked Questions

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

Has this intervention obtained clearance from the Food and Drug Administration?

"Our team at Power has cautiously awarded the safety of this treatment a score of 2, as it is currently in its Phase 2 trial stage. This implies there are some data supporting safety yet still no evidence to suggest efficacy."

Answered by AI

Is the age requirement for participation in this trial inclusive of individuals over 35?

"Per the parameters of this clinical trial, individuals must be between 50 and 70 years old to be eligible for enrollment."

Answered by AI

Is there an opportunity for me to join this medical experiment?

"To be qualified for this trial, applicants must have lymphoma and fall within the age bracket of 50 to 70. Approximately 40 participants will be selected."

Answered by AI

Are there any openings in this research program for participants?

"As indicated on clinicaltrials.gov, this specific medication trial is no longer recruiting participants; the post was published in March 2004 and last updated in February 2008. However, there are still 3753 other trials actively looking for patient volunteers at the moment."

Answered by AI
~2 spots leftby Apr 2025