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Transplantation

RIC + haplo-HCT for Blood Cancer

Q: What is the legal status of GVHD Prophylaxis?

Our assessment at Power gave GVHD prophylaxis a score of 2, as this phase 2 trial has some evidence showing safety but not efficacy.

Q: Is recruitment still open for this research project?

According to clinicaltrials.gov, this medical experiment is currently seeking participants; the original study was posted on January 24th 2017 and its information most recently updated on February 25th 2022.

Q: What is the cap on enrollment for this experiment?

Affirmative. Clinicaltrials.gov contains evidence that this clinical trial, which was initially established on January 24th 2017, is still seeking participants. 84 individuals are required to be recruited from a single medical centre.

Phase 2

Waitlist Available

Led By Najla El Jurdi, MD

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

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

Must have

Karnofsky performance status of ≥70% or Lansky play score ≥ 70%

Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 2 year

Awards & highlights

Study Summary

This trial is testing a new way to treat cancer with reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT). This study uses a two-stage phase II design with the goal of enrolling 84 patients.

Who is the study for?

This trial is for people aged between 55-75 with blood cancers who have a related donor partially matching their HLA type. They must be in good physical condition, not pregnant or breastfeeding, and free from serious infections or active central nervous system cancer. HIV+ patients can join if they have an undetectable viral load and a management plan.Check my eligibility

What is being tested?

The study tests a reduced intensity conditioning regimen followed by haploidentical hematopoietic cell transplant (haplo-HCT) in patients with blood cancers. It involves drugs like fludarabine, cyclophosphamide, melphalan and TBI, adjusting doses based on age and health conditions.See study design

What are the potential side effects?

Possible side effects include reactions to the drug infusion, damage to organs due to chemotherapy or radiation, increased risk of infections post-transplantation, graft-versus-host disease where the donor cells attack the patient's body, and general fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly able to care for myself and carry out daily activities.

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My heart functions well enough for treatment, without severe failure or uncontrolled irregular heartbeat.

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My lung function is above 40% of what's expected, and I don't need oxygen support.

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I have a family member who can donate bone marrow to me, even if we are not a perfect match.

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My donor and I match for at least one set of genetic markers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 and 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 and 2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 2 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Disease-free survival (DFS)

Secondary outcome measures

Incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD)

Incidence of serious fungal and viral infection

Relapse incidence

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: CLOSED Arm B: Haplo-HCT ≥55 years oldExperimental Treatment2 Interventions

Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.

Group II: Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3Experimental Treatment2 Interventions

Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.

Group III: Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yoExperimental Treatment2 Interventions

Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and < 65 years old.

Group IV: Arm A: Haplo-HCT <55 years oldExperimental Treatment2 Interventions

Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients <55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GVHD Prophylaxis

2002

Completed Phase 1

~20

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor

272 Previous Clinical Trials

14,575 Total Patients Enrolled

Najla El Jurdi, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota

1 Previous Clinical Trials

23 Total Patients Enrolled

Media Library

Reduced Intensity Conditioning And Transplantation of HLA-Haplo-HCT (Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT02988466 — Phase 2

Blood Cancers Research Study Groups: Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3, Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yo, Arm A: Haplo-HCT <55 years old, CLOSED Arm B: Haplo-HCT ≥55 years old

Blood Cancers Clinical Trial 2023: Reduced Intensity Conditioning And Transplantation of HLA-Haplo-HCT Highlights & Side Effects. Trial Name: NCT02988466 — Phase 2

Reduced Intensity Conditioning And Transplantation of HLA-Haplo-HCT (Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02988466 — Phase 2

Frequently Asked Questions

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

What is the legal status of GVHD Prophylaxis?

"Our assessment at Power gave GVHD prophylaxis a score of 2, as this phase 2 trial has some evidence showing safety but not efficacy."

Answered by AI

Is recruitment still open for this research project?

"According to clinicaltrials.gov, this medical experiment is currently seeking participants; the original study was posted on January 24th 2017 and its information most recently updated on February 25th 2022."

Answered by AI

What is the cap on enrollment for this experiment?

"Affirmative. Clinicaltrials.gov contains evidence that this clinical trial, which was initially established on January 24th 2017, is still seeking participants. 84 individuals are required to be recruited from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT

2017. "Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02988466.