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Chemotherapy

TBI for Burkitt Lymphoma

Phase 2
Waitlist Available
Led By Erica Warlick, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years post transplant
Awards & highlights

Study Summary

This trial is testing a new cancer treatment involving chemotherapy, radiation, and a stem cell transplant. The goal is to see if it can help prevent GVHD.

Eligible Conditions
  • Lymphoplasmacytic Lymphoma
  • Burkitt Lymphoma
  • Prolymphocytic Leukemia
  • Follicular Lymphoma
  • Myeloproliferative Syndrome
  • B-Cell Lymphoma
  • Lymphoblastic Lymphoma
  • Acute Lymphoblastic Leukemia
  • Mantle Cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • Acute Myeloid Leukemia
  • Multiple Myeloma
  • Blood Diseases
  • Leukemia
  • Myelodysplastic Syndrome
  • Chronic Lymphocytic Leukemia
  • Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years 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
Graft-vs-Host Disease
Secondary outcome measures
Evaluate neutrophil engraftment with ATG (in unrelated donors)
Evaluate neutrophil engraftment without ATG (in siblings)
Evaluate neutrophil engraftment without ATG (in unrelated donors)
+9 more

Side effects data

From 2020 Phase 2 trial • 35 Patients • NCT02120157
34%
Oral Mucositis
25%
Vomiting
25%
Diarrhea
16%
Hypomagnesemia
16%
Fever
13%
Hypokalemia
13%
Anorexia
13%
Nausea
13%
Veno-occlusive Disease/ Hepatic Sinusoidal Obstruction Syndrome
13%
Anemia
9%
Hypertension
9%
Graft Failure
9%
Platelet Count Decreased
9%
White Blood cells decreased
6%
Neutrophil Count Decreased
3%
Acute GVHD
3%
Broviac Cather Infection
3%
Intracranial Hemorrhage
3%
Cystitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Haploidentical BMT With PTCy for Acute Leukemias and MDS

Trial Design

1Treatment groups
Experimental Treatment
Group I: Reduced Intensity ConditioningExperimental Treatment9 Interventions
Non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
FDA approved
Mycophenolate mofetil
FDA approved
Peripheral Blood Stem Cells
2002
Completed Phase 2
~220
TBI
2014
Completed Phase 2
~1040
Related or Unrelated Bone Marrow Cells
2017
Completed Phase 2
~160
Allopurinol
FDA approved
Fludarabine
FDA approved
Cyclophosphamide
FDA approved
ATG
2016
Completed Phase 4
~1070

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,469 Total Patients Enrolled
8 Trials studying Burkitt Lymphoma
599 Patients Enrolled for Burkitt Lymphoma
Erica Warlick, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
3 Previous Clinical Trials
358 Total Patients Enrolled

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02661035 — Phase 2
Burkitt Lymphoma Research Study Groups: Reduced Intensity Conditioning
Burkitt Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02661035 — Phase 2
Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02661035 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Allo HSCT Using RIC for Hematological Diseases
2017. "Allo HSCT Using RIC for Hematological Diseases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02661035.
~19 spots leftby Apr 2025
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