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Alkylating agents

Bendamustine +/- Cyclophosphamide to Prevent GVHD Post Stem Cell Transplant for Blood Cancers

Phase 1 & 2

Recruiting

Led By Issa F Khouri

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Zubrod performance 0 to 2 or Karnofsky of at least 60.

Creatinine less than or equal to 1.6 mg/dL and creatinine clearance >= 30 ml/min. Creatine clearance will be calculated using the Cockcroft-Gault equation. (at time of study entry)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing bendamustine, with or without cyclophosphamide, to see if it can help prevent GVHD in patients undergoing stem cell transplant.

Who is the study for?

This trial is for blood cancer patients who need a stem cell transplant and have good lung function (FVC and FEV1 >= 40%), heart function (ejection fraction >= 40%), and kidney function (creatinine clearance >= 30 ml/min). They must have a donor that's mismatched or haplo-identical, be relatively fit (Zubrod performance 0 to 2 or Karnofsky ≥60), not HIV positive, without active hepatitis B/C, unresolved toxicities from prior treatments, certain active diseases/infections, or pregnant/nursing.Check my eligibility

What is being tested?

The study tests if bendamustine with/without cyclophosphamide can prevent GVHD after stem cell transplants. It includes chemotherapy drugs like melphalan and fludarabine, total-body irradiation before the transplant to kill cancer cells/make room for new cells in bone marrow, followed by tacrolimus and mycophenolate mofetil to potentially stop GVHD.See study design

What are the potential side effects?

Possible side effects include reactions from chemotherapy such as nausea, fatigue, hair loss; organ inflammation due to immune response; increased risk of infections post-transplant; complications from radiation like skin irritation; plus potential issues related to immunosuppressants such as tacrolimus.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but may not be able to do heavy physical work.

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My kidney function, measured by creatinine levels, is within the required range.

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I have a blood cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Dose-limiting toxicity (Phase I)

Incidence of adverse events (Phase II)

Maximum tolerated dose level (MTDL) (Phase I)

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575

Hypoxia

Febrile neutropenia

Acute kidney injury

Blood bilirubin increased

Diarrhea

Creatinine increased

Sepsis

Hypotension

Left ventricular systolic dysfunction

Bronchopulmonary hemorrhage

Chronic kidney disease

Thromboembolic event

Lung infection

Atrial fibrillation

Atrial flutter

Hemolysis

Hemolytic uremic syndrome

Ejection fraction decreased

Encephalitis infection

Gastric hemorrhage

Gastritis

Heart failure

Mucositis oral

Multi-organ failure

Myalgia

Pleural effusion

Respiratory failure

Small intestine infection

Syncope

Treatment related secondary malignancy

Typhlitis

Fever

Paroxysmal atrial tachycardia

Ascites

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Fludarabine, Transplant, Immunosuppression)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Schedule II (lymphoid malignancies)Experimental Treatment9 Interventions

Patients receive fludarabine IV over 1 hour, bendamustine IV over 30-60 minutes on days -5 to -3 and undergo TBI on day -1 and stem cell transplantation over 2-6 hours on day 0. Depending on when the trial was joined, patients receive cyclophosphamide IV over 3 hours or bendamustine IV over 30-60 minutes or cyclophosphamide IV over 3 hours and bendamustine IV over 30-60 minutes on day 3. Patients also receive bendamustine IV over 30-60 minutes on day 4. Beginning day 5, patients receive tacrolimus IV followed by PO QD or BID for 6 months and mycophenolate mofetil PO TID until day 100. Beginning day 7, patients receive filgrastim-sndz SC QD until blood cell levels return to normal. CD20+ patients receive rituximab IV over 4-6 hours on days -13, -6, 1, and 8.

Group II: Schedule I (non-lymphoma)Experimental Treatment9 Interventions

Patients receive fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on days -5 and -4, and undergo TBI on day -1 and stem cell transplantation IV over 2-6 hours on day 0. Depending on when the trial was joined, patients receive cyclophosphamide IV over 3 hours or bendamustine IV over 30-60 minutes or cyclophosphamide IV over 3 hours and bendamustine IV over 30-60 minutes on day 3. Patients also receive bendamustine IV over 30-60 minutes on day 4. Beginning day 5, patients receive tacrolimus IV followed by PO QD or BID for 6 months and mycophenolate mofetil PO TID until day 100. Beginning day 7, patients receive filgrastim-sndz SC QD until blood cell levels return to normal.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1200

Cyclophosphamide

1995

Completed Phase 3

~3770

Bendamustine

2015

Completed Phase 3

~2950

Filgrastim-sndz

2017

Completed Phase 2

~40

Melphalan

2008

Completed Phase 3

~1500

Fludarabine

2012

Completed Phase 3

~1100

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

Tacrolimus

2011

Completed Phase 4

~4740

Total-Body Irradiation

1997

Completed Phase 3

~1180

Rituximab

1999

Completed Phase 4

~1880

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,762 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,627 Total Patients Enrolled

1 Trials studying Blood Cancers

70 Patients Enrolled for Blood Cancers

Issa F KhouriPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

44 Total Patients Enrolled

Media Library

Bendamustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04022239 — Phase 1 & 2

Blood Cancers Research Study Groups: Schedule II (lymphoid malignancies), Schedule I (non-lymphoma)

Blood Cancers Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT04022239 — Phase 1 & 2

Bendamustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04022239 — Phase 1 & 2

Frequently Asked Questions

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

In what medical conditions is Allogeneic Hematopoietic Stem Cell Transplantation most commonly employed?

"Allogeneic Hematopoietic Stem Cell Transplantation is a widely accepted treatment for lung cancer and has been used to assuage the symptoms of dermatitis, atopic, multiple sclerosis, and b-cell lymphomas."

Answered by AI

Who qualifies to take part in this medical experiment?

"To be considered, applicants must suffer from neoplasms and range in age between 18-70 years old. This medical study is currently seeking approximately 40 participants."

Answered by AI

Are there any other experiments involving Allogeneic Hematopoietic Stem Cell Transplantation that have been conducted previously?

"Currently, 1361 studies related to Allogeneic Hematopoietic Stem Cell Transplantation are in progress. Of these trials, 260 have reach Phase 3 status. The majority of research for this therapy has been conducted at Bethesda, Maryland; however, 40052 sites globally offer the treatment."

Answered by AI

Does this trial include elderly individuals in its recruitment efforts?

"According to the criteria listed, only individuals aged between 18-70 are eligible for enrolment. However, there are 392 studies available for minors and 1101 trials catered towards persons over 65 years old."

Answered by AI

Is this medical research project accepting participants presently?

"According to the details of this trial hosted on clinicaltrials.gov, enrolment for participants is currently open. The experiment was initially announced on March 13th 2020 and has been modified most recently on September 7th 2022."

Answered by AI

What is the upper bound of participants involved in this experiment?

"Affirmative, clinicaltrials.gov attests to this study's ongoing recruitment efforts. The trial kicked off back on March 13th 2020 and was updated most recently on September 7th 2022. 40 participants are required from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant

2020. "Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04022239.

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