Study Summary
This trial is testing a new combination of chemotherapy and low-dose radiation to see if it is safe and effective in treating bone marrow cancer. The CliniMACS device is approved for one type of T cell depletion but not the type being studied in this trial. This trial will help determine if the CliniMACS device should be approved for the other type of T cell depletion.
Eligible Conditions
- Myeloid Diseases
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 30 days post-transplant
30 days post-transplant
Rate of donor Neutrophil Engraftment
Trial Safety
Safety Progress
Side Effects for
Treatment (Fludarabine, Transplant, Immunosuppression)
5%Febrile neutropenia
5%Hypoxia
5%Acute kidney injury
4%Blood bilirubin increased
4%Creatinine increased
4%Diarrhea
4%Sepsis
3%Bronchopulmonary hemorrhage
3%Chronic kidney disease
3%Hypotension
3%Lung infection
3%Left ventricular systolic dysfunction
3%Thromboembolic event
1%Gastric hemorrhage
1%Atrial fibrillation
1%Atrial flutter
1%Heart failure
1%Mucositis oral
1%Pleural effusion
1%Syncope
1%Multi-organ failure
1%Typhlitis
1%Respiratory failure
1%Treatment related secondary malignancy
1%Fever
1%Ejection fraction decreased
1%Paroxysmal atrial tachycardia
1%Gastritis
1%Hemolytic uremic syndrome
1%Ascites
1%Encephalitis infection
1%Hemolysis
1%Myalgia
1%Small intestine infection
Trial Design
1 Treatment Group
Patients with Myeloid Malignancies & Aplastic Anemia
1 of 1
Experimental Treatment
15 Total Participants · 1 Treatment Group
Primary Treatment: Allogeneic Hematopoietic Stem Cell Transplantation · No Placebo Group · Phase 1
Patients with Myeloid Malignancies & Aplastic AnemiaExperimental Group · 6 Interventions: Allogeneic Hematopoietic Stem Cell Transplantation, Rituxan, cyclophosphamide, total body irradiation, fludarabine, Antithymocyte globulin (Rabbit) · Intervention Types: Procedure, Drug, Drug, Radiation, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1280
Rituximab
FDA approved
Cyclophosphamide
FDA approved
total body irradiation
2010
Completed Phase 3
~920
Fludarabine
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days post-transplant
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,523 Total Patients Enrolled
Roni Tamari, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
125 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a cytogenetic abnormality which is not considered a good risk cytogenetic feature.
Intended recipients of heart transplantation are those with a high risk of early death.
You have chronic myelomonocytic leukemia (CMML).
Patients who have failed or are intolerant to BCR-ABL tyrosine kinase inhibitors.
The patient has BCR-ABL mutation consistent with poor response to tyrosine kinase inhibitor therapy.
You have chronic lymphocytic leukemia (CLL) with high risk disease as defined by the EBMT consensus criteria.
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Conditions
Cancer Related
Treatments