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Proteasome Inhibitor
Cyclophosphamide for Stem Cell Transplantation
Phase 2
Waitlist Available
Led By Jeremy Ramdial, Ramdial
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
For children < 7 years of age who are unable to perform PFT, oxygen saturation > 92% on room air by pulse oximetry.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial looked at the outcomes of using different immunosuppressants and conditioning regimens before an allogeneic stem cell transplant in patients with inherited blood disorders.
Eligible Conditions
- Stem Cell Transplantation
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
If you're a child under 7 years old and can't do a lung function test, your oxygen levels need to be above 92% when measured with a pulse oximeter while breathing normal air.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the 100-day non-relapse mortality (NRM) rate when administering pharmacologic pretransplant immunosuppression (PTIS) followed by pretransplant reduced toxicity conditioning (RTC
Side effects data
From 2023 Phase 2 trial • 27 Patients • NCT0400240188%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Diarrhoea
31%
Hypokalaemia
31%
Tachycardia
27%
Back pain
27%
Constipation
27%
Hypophosphataemia
23%
B-cell lymphoma
23%
White blood cell count decreased
23%
Tremor
23%
Platelet count decreased
23%
Dizziness
19%
Agitation
19%
Cough
19%
Hypogammaglobulinaemia
19%
Tachypnoea
19%
Oedema peripheral
19%
Neutropenia
19%
Hyponatraemia
15%
Hypomagnesaemia
15%
Dysphagia
15%
Dyspnoea
15%
Chills
15%
Thrombocytopenia
15%
Alanine aminotransferase increased
15%
Sinus tachycardia
12%
Arthralgia
12%
Aspartate aminotransferase increased
12%
Hypoxia
12%
Myalgia
12%
Malaise
12%
Abdominal pain
12%
Pain
12%
Hypertension
12%
Peripheral sensory neuropathy
12%
Vomiting
12%
Covid-19
12%
Hyperglycaemia
8%
Acute myeloid leukaemia
8%
Aphasia
8%
Pancytopenia
8%
Dysuria
8%
Hyperhidrosis
8%
Lymphocyte count decreased
8%
Gait disturbance
8%
Pneumonia
8%
Sepsis
8%
Oral candidiasis
8%
Muscular weakness
8%
Encephalopathy
8%
Somnolence
8%
Blood creatinine increased
8%
Urinary tract infection
8%
Eye pain
8%
Asthenia
8%
Insomnia
4%
Respiratory failure
4%
Syncope
4%
Depression
4%
Covid-19 pneumonia
4%
Embolism
4%
Pleural effusion
4%
Febrile neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase II: RTC Regimen and GVHD Prophylaxis Based on Post-CyExperimental Treatment7 Interventions
Group II: Phase I: Sequential Pharmacological PTISExperimental Treatment8 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Bortezomib
2005
Completed Phase 2
~1140
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1090
Busulfan
2008
Completed Phase 3
~1120
Rituximab
1999
Completed Phase 4
~1880
Mycophenolate mofetil (MMF)
2008
Completed Phase 3
~2250
Rabbit ATG
2001
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,449 Total Patients Enrolled
Jeremy Ramdial, RamdialPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Phase I: Sequential Pharmacological PTIS
- Group 2: Phase II: RTC Regimen and GVHD Prophylaxis Based on Post-Cy
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any Cyclophosphamide safety concerns that patients should be made aware of?
"While there is some clinical data suggesting that Cyclophosphamide is safe, it remains a Phase 2 medication because there is no evidence of its efficacy."
Answered by AI
Are there still vacancies in this program for people who want to participate?
"The clinicaltrials.gov website shows that this research is not currently looking for candidates. The posting date was September 30th, 2022 and the last edit was on May 4th, 2022. Even though this study isn't ongoing, there are 76 other trials that patients can participate in."
Answered by AI
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