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Alkylating agents

Cyclophosphamide After Stem Cell Transplant for Blood Cancer (GeriBMT Trial)

Phase 1
Recruiting
Led By Ronald Paquette, MD
Research Sponsored by Ronald Paquette
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year post-transplant
Awards & highlights

GeriBMT Trial Summary

This trial will test a drug to help older people with blood cancers after stem cell transplants.

Who is the study for?
This trial is for patients aged 70 or older with blood cancers who need a stem cell transplant and have a related donor that's a half-match for their immune system. They must be able to handle a specific pre-transplant treatment and both patient and donor must agree to the study rules.Check my eligibility
What is being tested?
The study is testing different doses of cyclophosphamide, an immune-suppressing drug, after standard stem cell transplants in elderly patients with blood cancers, to find the safest and most effective dose.See study design
What are the potential side effects?
Cyclophosphamide can cause side effects like nausea, hair loss, mouth sores, low blood counts leading to infection risk or bleeding problems, bladder irritation, and possibly infertility.

GeriBMT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year 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
Maximum grade acute GVHD by day +100 by Modified Keystone Criteria
Secondary outcome measures
Change in active daily living
Change in cardiac function
Change in cognitive function
+11 more

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401
88%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Hypokalaemia
31%
Diarrhoea
31%
Tachycardia
27%
Constipation
27%
Back pain
27%
Hypophosphataemia
23%
Dizziness
23%
Platelet count decreased
23%
Tremor
23%
B-cell lymphoma
23%
White blood cell count decreased
19%
Oedema peripheral
19%
Neutropenia
19%
Cough
19%
Hypogammaglobulinaemia
19%
Hyponatraemia
19%
Tachypnoea
19%
Agitation
15%
Alanine aminotransferase increased
15%
Thrombocytopenia
15%
Chills
15%
Dyspnoea
15%
Hypomagnesaemia
15%
Sinus tachycardia
15%
Dysphagia
12%
Hypertension
12%
Vomiting
12%
Abdominal pain
12%
Aspartate aminotransferase increased
12%
Pain
12%
Malaise
12%
Myalgia
12%
Hypoxia
12%
Arthralgia
12%
Hyperglycaemia
12%
Covid-19
12%
Peripheral sensory neuropathy
8%
Hyperhidrosis
8%
Aphasia
8%
Pancytopenia
8%
Muscular weakness
8%
Pneumonia
8%
Encephalopathy
8%
Eye pain
8%
Gait disturbance
8%
Oral candidiasis
8%
Urinary tract infection
8%
Sepsis
8%
Blood creatinine increased
8%
Acute myeloid leukaemia
8%
Insomnia
8%
Somnolence
8%
Dysuria
8%
Asthenia
8%
Lymphocyte count decreased
4%
Pleural effusion
4%
Covid-19 pneumonia
4%
Respiratory failure
4%
Febrile neutropenia
4%
Embolism
4%
Depression
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination

GeriBMT Trial Design

1Treatment groups
Experimental Treatment
Group I: Open ArmExperimental Treatment1 Intervention
All patients will receive cyclophosphamide on Day +3 and Day +4 following transplant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Ronald PaquetteLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Ronald Paquette, MDPrincipal InvestigatorCedars-Sinai Medical Center
5 Previous Clinical Trials
76 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05849207 — Phase 1
Blood Cancers Research Study Groups: Open Arm
Blood Cancers Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05849207 — Phase 1
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05849207 — Phase 1

Frequently Asked Questions

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

Are there current opportunities to join this experiment?

"Clinicaltrials.gov reveals that this trial, which was first publicized on July 1st 2023 and last updated on May 5th 2023, is no longer enrolling participants. However, 283 other studies are actively searching for clinical test subjects at the moment."

Answered by AI

Has the Open Arm technology been certified by the FDA?

"Given the Phase 1 status of this trial, our team at Power gave Open Arm a score of 1 to reflect its lack of established safety and efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Post-Transplant Cyclophosphamide in Patients Aged >/= 70 Years Undergoing Haploidentical Transplant
Ronald Paquette 2023. "Post-Transplant Cyclophosphamide in Patients Aged >/= 70 Years Undergoing Haploidentical Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05849207.
~17 spots leftby Jul 2027
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