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Alkylating agents
Chemotherapy + Stem Cell Transplant for Blood Cancers
Phase 2
Waitlist Available
Led By Uday R Popat, MD
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
Left ventricular ejection fraction >= 50%
Adequate pulmonary function with forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of expected corrected for hemoglobin and/or volume; children unable to perform pulmonary function tests (e.g., less than 7 years old) pulse oximetry of >= 92% on room air
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trialstudies the side effects of drugs used to stop the growth of cancer cells before & after a stem cell transplant.
Who is the study for?
This trial is for patients with high-risk blood cancers like various leukemias, lymphomas, and myeloma. They should have a poor prognosis without transplant therapy and can be in remission or relapsed. Participants need functioning major organs, no active hepatitis B/C or HIV, not pregnant nor breastfeeding, willing to use contraception if applicable, and must have a suitable donor for stem cell transplant.Check my eligibility
What is being tested?
The study tests busulfan and fludarabine phosphate chemotherapy followed by donor stem cell transplant with post-transplant cyclophosphamide treatment. It aims to see how well these drugs work together to stop cancer growth by killing cells or preventing their spread while reducing the risk of graft-versus-host disease.See study design
What are the potential side effects?
Potential side effects include damage to bone marrow (affecting blood cell production), immune system reactions against normal body cells (graft-versus-host disease), organ inflammation from the immune response, increased infection risk due to weakened immunity, nausea, hair loss from chemotherapy agents used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart pumps blood well.
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My lung function tests are within normal limits, or if I'm a child under 7, my oxygen level is 92% or higher on room air.
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My kidneys are functioning well enough to filter waste.
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I have a high-risk blood cancer with a poor outlook without transplant.
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I have a closely matched or half-matched family member or unrelated donor for my treatment.
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I am mostly active and can care for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Non-relapse mortality rate
Secondary outcome measures
Graft versus host disease-free survival/relapse free survival
Bone Transplantation
Incidence of grade 3 and 4 adverse events
+5 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Group VI (matched or haploidentical transplant, chemotherapy)Experimental Treatment10 Interventions
Patients receiving fully matched or haploidentical donor transplant receive busulfan IV over 3 hours on days -20, -13, and -6 to -3, a lower dose of thiotepa IV over 4 hours on day -7, fludarabine phosphate IV over 1 hour on days -6 to -3. Patients undergo stem cell transplantation IV on day 0. Patients then receive cyclophosphamide IV over 3 hours on days 3 and 4. Beginning on day 5, patients receive tacrolimus IV continuously or PO BID for up to 3 months and mycophenolate mofetil PO TID.
Group II: Group V (haploidentical donor transplant, chemotherapy)Experimental Treatment10 Interventions
Patients receive busulfan IV over 3 hours on days -20, -13, and -6 to -3, a lower dose of thiotepa IV over 4 hours on day -7, fludarabine phosphate IV over 1 hour on days -6 to -3. Patients undergo stem cell transplantation IV on day 0. Patients then receive cyclophosphamide IV over 3 hours on days 3 and 4. Beginning on day 5, patients receive tacrolimus IV continuously or PO BID for up to 3 months and mycophenolate mofetil PO TID.
Group III: Group IV (matched donor transplant, chemotherapy)Experimental Treatment8 Interventions
Patients receiving haploidentical related donor transplant, diagnosis of myelofibrosis, > 60 years old, or patients with comorbidity scores > 3 will go in Group 3 or 4. If patients with comorbidity score >3, then the principal investigator is the final arbiter of eligibility for comorbidity score > 3. Busulfan is administered at the dose calculated to achieve a total (including first two doses delivered on day -20 and day -13) system exposure of 20,000 +/- 12% uMol-min based on the pharmacokinetic studies.
Group IV: Group III (haploidentical donor transplant, chemotherapy)Experimental Treatment10 Interventions
Patients receiving haploidentical related donor transplant, diagnosis of myelofibrosis, > 60 years old, or patients with comorbidity scores > 3 will go in Group 3 or 4. If patients with comorbidity score > 3, then the principal investigator is the final arbiter of eligibility for comorbidity score > 3. Busulfan is administered at the dose calculated to achieve a total (including first two doses delivered on day -20 and day -13) system exposure of 20,000 +/- 12% uMol-min based on the pharmacokinetic studies.
Group V: Group II (matched donor transplant, chemotherapy)Experimental Treatment8 Interventions
Patients receive busulfan IV over 3 hours on days -13, -12, and -6 to -3, fludarabine phosphate IV over 1 hour on days -6 to -3. Patients undergo stem cell transplantation IV on day 0. Patients then receive cyclophosphamide IV over 3 hours on days 3 and 4. Beginning on day 5, patients receive tacrolimus IV continuously or PO BID for up to 3 months.
Group VI: Group I (haploidentical donor transplant, chemotherapy)Experimental Treatment10 Interventions
Patients receive busulfan IV over 3 hours on days -13, -12, and -6 to -3, thiotepa IV over 4 hours on day -7, fludarabine phosphate IV over 1 hour on days -6 to -3. Patients undergo stem cell transplantation IV on day 0. Patients then receive cyclophosphamide IV over 3 hours on days 3 and 4. Beginning on day 5, patients receive tacrolimus IV continuously or PO BID for up to 3 months and mycophenolate mofetil PO TID.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
2011
Completed Phase 4
~4740
Busulfan
2008
Completed Phase 3
~1120
Cyclophosphamide
1995
Completed Phase 3
~3770
Thiotepa
2008
Completed Phase 3
~2150
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,095 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,068 Total Patients Enrolled
Uday R Popat, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
51 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with inotuzumab or gemtuzumab.My heart pumps blood well.My lung function tests are within normal limits, or if I'm a child under 7, my oxygen level is 92% or higher on room air.My kidneys are functioning well enough to filter waste.Your bilirubin levels are not more than twice the normal limit, unless you have certain conditions that can cause higher bilirubin levels.I have a high-risk blood cancer with a poor outlook without transplant.I have a closely matched or half-matched family member or unrelated donor for my treatment.I am HIV positive.I have had heart disease related to my arteries.I have had a transplant from a donor.I have active hepatitis B or C.I am mostly active and can care for myself.You have multiple other health conditions that add up to a high score, and the main doctor will decide if you can participate.Your SGPT (ALT) levels are less than 200.I do not have any infections that are not responding to treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group V (haploidentical donor transplant, chemotherapy)
- Group 2: Group VI (matched or haploidentical transplant, chemotherapy)
- Group 3: Group I (haploidentical donor transplant, chemotherapy)
- Group 4: Group IV (matched donor transplant, chemotherapy)
- Group 5: Group III (haploidentical donor transplant, chemotherapy)
- Group 6: Group II (matched donor transplant, chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research include data from patients who are 85 years old or older?
"The age range for patients that this clinical trial is recruiting are those between 12 and 75 years old."
Answered by AI
Has the FDA given their okay to Group III's (haploidentical donor transplant, chemotherapy) method?
"Since Phase 2 trials have limited data supporting safety, but none for efficacy, our team at Power has given Group III (haploidentical donor transplant, chemotherapy) a score of 2."
Answered by AI
How many people are included in this experiment?
"Unfortunately, this particular trial is not currently looking for more patients. Although, according to the latest update on October 6th 2022, it was originally posted on August 5th 2016. There are 8076 other trials concerning multiple myeloma enrolling participants and 1074 studies for Group III (haploidentical donor transplant, chemotherapy) that are actively seeking patients."
Answered by AI
Are there precedents for this Group III (haploidentical donor transplant, chemotherapy) medical trial?
"At the moment, there are 1074 ongoing clinical trials studying Group III treatments (haploidentical donor transplant, chemotherapy). Out of these research projects, 187 are in Phase 3. Most of the clinical trials for Group III treatments are taking place in Philadelphia, but there are almost 30 000 locations worldwide where these studies are happening."
Answered by AI
When is Group III (haploidentical donor transplant, chemotherapy) the best course of action?
"Group III (haploidentical donor transplant, chemotherapy) is a standard treatment for lung cancers. It can also be taken to treat dermatitis, atopic conditions, multiple sclerosis, leukemia, myelocytic disorders, and acute conditions."
Answered by AI
Are there any positions available for volunteers in this research?
"Unfortunately, this particular trial is not currently looking for new patients. However, there are over 9000 other trials that might be a match for you."
Answered by AI
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