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Allogeneic Hematopoietic Stem Cell Transplantation for Mantle Cell Lymphoma

Phase < 1
Waitlist Available
Led By Roger Strair
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient with disease (stage) eligible per cohort
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks of completion of therapy
Awards & highlights

Study Summary

This trial is testing whether transfusions of immune cells from relatives can help control cancer in patients receiving a stem cell transplant.

Eligible Conditions
  • Mantle Cell Lymphoma
  • Chromosome 17p Deletion
  • Multiple Myeloma
  • Non-Hodgkin's Lymphoma
  • Bone Marrow Transplant Recipient
  • JAK2 Mutation
  • RASopathy
  • Diffuse Large B-Cell Lymphoma
  • Hematologic Malignancy
  • T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • TP53
  • B-Cell Lymphoma
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Minimal Residual Disease
  • Myelodysplastic Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your disease is at a stage that fits the requirements for this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks of completion of therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks of completion of therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response
the Number of Participants With Toxicities Associated With Administration of Irradiated Haploidentical Cells (IHC) Evaluated According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Secondary outcome measures
Induction of Host T Cells Reactive With Tumor Associated Epitopes

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575
5%
Hypoxia
5%
Febrile neutropenia
5%
Acute kidney injury
4%
Blood bilirubin increased
4%
Diarrhea
4%
Creatinine increased
4%
Sepsis
3%
Hypotension
3%
Left ventricular systolic dysfunction
3%
Bronchopulmonary hemorrhage
3%
Chronic kidney disease
3%
Thromboembolic event
3%
Lung infection
1%
Atrial fibrillation
1%
Atrial flutter
1%
Hemolysis
1%
Hemolytic uremic syndrome
1%
Ejection fraction decreased
1%
Encephalitis infection
1%
Gastric hemorrhage
1%
Gastritis
1%
Heart failure
1%
Mucositis oral
1%
Multi-organ failure
1%
Myalgia
1%
Pleural effusion
1%
Respiratory failure
1%
Small intestine infection
1%
Syncope
1%
Treatment related secondary malignancy
1%
Typhlitis
1%
Fever
1%
Paroxysmal atrial tachycardia
1%
Ascites
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Fludarabine, Transplant, Immunosuppression)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort II (initial IHC within 70 days or after relapse)Experimental Treatment2 Interventions
Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.
Group II: Cohort I (initial IHC within 42 days)Experimental Treatment2 Interventions
Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
424 Previous Clinical Trials
64,131 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,644 Total Patients Enrolled
Roger Strair5.07 ReviewsPrincipal Investigator - Rutgers Cancer Institute of New Jersey
Rutgers Cancer Institute of New Jersey
6 Previous Clinical Trials
69 Total Patients Enrolled
5Patient Review
I couldn't have ask for a more trusted, educated, and empathetic doctor. He is truly the best.

Frequently Asked Questions

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

Is the research team currently onboarding participants for this trial?

"According to clinicaltrials.gov, this investigation is not currently accepting participants; the trial was initially published on October 26th 2020 and last updated on November 29th 2022. At present, there are 7956 other trials seeking recruits."

Answered by AI
~0 spots leftby Mar 2025