Status:
COMPLETED
Combination Chemotherapy, Total Body Irradiation, and Donor Blood Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Primary Myelofibrosis
Secondary Myelofibrosis
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
This early phase I trial studies the side effects of combination chemotherapy, total body irradiation, and donor blood stem cell transplant in treating patients with primary or secondary myelofibrosis...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability of reduced-intensity (FM) haploidentical hematopoietic cell transplantation (Haplo-HCT) followed by post-transplant cyclophosphamide (PTC...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of primary or secondary Myelofibrosis with transplant indication by DIPSS-plus (\> intermediate -1);
- Age 18-70; patients \>/= age 50 must have an comorbidity score (HCT-CI) \</= 4 (Sorror). The Principal Investigator is the final arbiter for comorbidity;
- Patients can be in chronic phase (CP) with BM blast count \</= 10% or after progression to AML and achieved \</= 5% BM blasts (morphologic CR prior to transplant);
- Lack of an HLA matched donor or need to proceed fast to transplantation when a patient does not have an immediately available matched unrelated donor (typed by high-resolution in the registry);
- Performance status \>/=70% (Karnofsky); patients \> 50 years should have adequate cognitive function; any concerns regarding cognitive function should be addressed by a Geriatrician/Neurologist;
- Adequate organ function: ALT/AST/billirubin \</= 5X UNL, creatinine clearance \> 50mls/min (calculated with Cockroft-Gault formula); LVEF \>/= 50%, DLCOc \>/= 50%;
- Prior treatment with JAK2 inhibitor therapy is not excluded. Patients on a JAK2 inhibitor may continue through conditioning until Day -3 then tapered at the discretion of the investigator.
- Exclusion:
- Evidence of portal hypertension with varices, ascites, or hepatic encephalopathy;
- \>10% bone marrow blasts at transplant if no history of AML and \>5% if had previous progression to AML;
- HIV positive; active hepatitis B or C;
- Patients with active infections. The PI is the final arbiter of the eligibility;
- Liver cirrhosis;
- Prior CNS involvement by tumor cells;
- Severe pulmonary hypertension (PHT) (On echo or right side cardiac catheterization);
- History of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-melanoma skin cancer, fully excised melanoma in situ \[Stage 0\], curatively treated localized prostate cancer, and cervical or breast carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear);
- Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization;
- Noncompliance - Inability or unwillingness to comply with medical recommendations regarding therapy or follow-up, including smoking tobacco. Smoking cessation is a standard teaching practice prior to admission for all patients undergoing stem cell transplant. Any patient who refuses to stop smoking prior to transplant will not be eligible for this study.
Exclusion
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03426969
Start Date
January 31 2018
End Date
September 21 2020
Last Update
October 14 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030