Lymphoma, Non-Hodgkin Clinical Trial
Official title:
Peripheral Blood Stem Cell Allotransplantation For Hematological Malignancies Using Ex Vivo CD34 Selection - a Platform For Adoptive Cellular Therapies
Verified date | June 28, 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background:
- Researchers are working to make stem cell transplant procedures safer and more effective.
One complication of transplants is graft-versus-host disease (GVHD). This complication
happens when certain white blood cells from the donor attack the recipient's own body.
Researchers want to test a blood separator machine that may help remove more of the donor's
white blood cells before transplant. They will study donors and recipients during stem cell
transplant to see how well this process can prevent GVHD and other complications.
Objectives:
- To see if a new blood separator machine can improve outcomes of stem cell transplants.
Eligibility:
- Individuals between 10 and 75 years of age who are having a stem cell transplant for
leukemia or other blood-related cancers.
- Donors for the stem cell transplant.
Design:
- Recipients and donors will be screened with a physical exam and medical history.
- Donors will have two blood collection procedures. The first will collect only white
blood cells, and return the rest of the blood. After the first collection, participants
will have filgrastim injections to help their stem cells enter their blood. Then, they
will have a second blood collection for the stem cells.
- Recipients will have radiation and chemotherapy to prepare for the stem cell transplant.
They will then have the stem cell transplant with the donor cells that have been treated
with the blood separator machine.
- Recipients will be monitored closely after the procedure. They may receive some of their
donor's white blood cells if needed to fight serious infections.
- Recipients will have the regular standard of care after their transplant. Blood samples
will be taken and any side effects will be monitored and treated.
Status | Completed |
Enrollment | 41 |
Est. completion date | June 28, 2018 |
Est. primary completion date | May 23, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 80 Years |
Eligibility |
- INCLUSION CRITERIA RECIPIENT 5.1.1 Ages 10-80 years inclusive 5.1.2 Any one of the following hematologic conditions, confirmed by pathology, meeting a standard indication for allogeneic stem cell transplant: 5.1.2.1 Chronic myelogenous leukemia (CML): Subjects under the age of 21 in chronic phase OR Subjects ages 10-80 in chronic phase who have failed or are intolerant to treatment with second generation tyrosine inhibitors OR Subjects ages 10-80 in accelerated phase or blast transformation. OR 5.1.2.2 Acute lymphoblastic leukemia (ALL): any of these categories: Adult ALL including standard risk; Pediatric ALL in first remission with high-risk features (presenting leukocyte count >100,000/cu mm, karyotypes t(9; 22), t4, t19, t11, biphenotypic leukemia). All second or subsequent remissions, primary induction failure, partially responding or untreated relapse. OR 5.1.2.3 Acute myelogenous leukemia (AML): AML in first remission - except AML with good risk karyotypes: AML M3 (t15; 17), AML M4Eo (inv 16), c-kit unmutated AML t (8; 21). All AML in second or subsequent remission, primary induction failure and resistant relapse. OR 5.1.2.4 Myelodysplastic syndromes(MDS): any of these categories - refractory anemia with transfusion dependence, refractory anemia with ANC<500/microL, refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia, atypical MDS/myeloproliferative syndromes. OR 5.1.2.5 Myeloproliferative disorders including atypical (Ph-negative) chronic myeloid and neutrophilic leukemias, progressing myelofibrosis, and polycythemia vera, essential thrombocythemia either in transformation to acute leukemia or with progressive transfusion requirements or pancytopenia. OR 5.1.2.6 Chronic lymphocytic leukemia refractory to fludarabine treatment and with bulky progressive disease or with thrombocytopenia (less than or equal to 100,000 / microl) or anemia (less than or equal to 10g/dl) not due to recent chemotherapy. OR 5.1.2.7 Non-Hodgkin s lymphoma including Mantle cell lymphoma relapsing or refractory to standard of care treatments. OR 5.1.2.8 Multiple myeloma, Waldenstroms macroglobulinemia, unresponsive or relapsed following standard of care treatments. OR 5.1.2.9 Hodgkin's Lymphoma relapsing following an autologous transplant. OR 5.1.2.10 Other rare hematologic malignancies for which hematopoietic stem cell transplantation has been performed and offers a durable remission or as the only option for potential for cure. - Chemotherapy-resistant multisystem Langerhans cell histiocytosis (MSLCH) especially involving organs like the bone marrow, liver, spleen, and lungs - Aggressive systemic mastocytosis, and mast cell leukemia (MCL) in first CR (CR1) - Hypereosinophilic syndrome who have failed imatinib therapy or FIP1L1-PDGFRa-negative patients who develop end-organ dysfunction - Adult T-cell leukemia/lymphoma at first diagnosis - Refractory or disseminated nasal-type extranodal NK/T-lymphoma or aggressive Natural killer cell leukemia/lymphoma - Mycosis fungoides and S(SqrRoot)(Copyright)zary syndrome after failure of two or three initial therapies - Primary or relapsed refractory Angioimmunoblastic T-cell lymphoma at first diagnosis - Hepatosplenic T-cell lymphoma (gamma/delta T-cell lymphoma) at first diagnosis - T-cell prolymphocytic leukemia at first diagnosis - Subcutaneous panniculitic T-cell lymphoma at first diagnosis - Hematodermic neoplasm (blastic natural killer cell lymphoma or Blastic plasmacytoid dendritic cell neoplasm) at first diagnosis 5.1.3 HLA identical (6/6) related donor. 5.1.4 For adults: ability to comprehend the investigational nature of the study and provide informed consent. For minors: written informed consent from one parent or guardian. Informed oral assent from minors: the process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend. EXCLUSION CRITERIA RECIPIENT (any of the following) 5.2.1 Major anticipated illness or organ failure incompatible with survival from transplant 5.2.2 Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and making informed consent impossible. 5.2.3 Positive pregnancy test for women of childbearing age 5.2.4 DLCO adjusted for Hb and ventilation< 50% predicted 5.2.5 Left ventricular ejection fraction < 40% (evaluated by ECHO) or < 30% (evaluated by MUGA) 5.2.6 AST/SGOT > 10 times ULN 5.2.7 Total bilirubin > 5 times ULN 5.2.8 Estimated GFR < 15 mL/min 5.2.9 Recipients who have active infections with HIV or active hepatitis C (HCV) INCLUSION CRITERIA DONOR 5.3.1 Related donor, HLA identical (6/6) with recipient 5.3.2 Weight greater than or equal to 18 kg 5.3.3 Age greater than or equal to 2 or less than or equal to 80 years old 5.3.4 For adults: ability to comprehend the investigational nature of the study and provide informed consent. For minors: written informed consent from one parent or guardian and informed assent: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend. EXCLUSION CRITERIA DONOR (any of the following) 5.4.1 Pregnant or breast-feeding. Lactating donors are permitted provided breast milk is discarded during the days filgrastim (G-CSF) is given 5.4.2 Unfit to receive G-CSF and undergo apheresis (abnormal blood counts, history of stroke, uncontrolled hypertension) 5.4.3 Sickling hemoglobinopathy including HbSS, HbSC 5.4.4 Donors who are positive for HIV, active hepatitis B (HBV), hepatitis C (HCV) or human Tcell lymphotropic virus (HTLV-I/II) 5.4.5 Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the donation process unlikely, and making informed consent impossible. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) | Children's National Research Institute |
United States,
Appelbaum FR. Haematopoietic cell transplantation as immunotherapy. Nature. 2001 May 17;411(6835):385-9. Review. — View Citation
Armitage JO. Bone marrow transplantation. N Engl J Med. 1994 Mar 24;330(12):827-38. Review. — View Citation
Barrett AJ. Graft-versus-host disease: basic considerations. Recent Results Cancer Res. 1993;132:185-95. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | Determine the rate of overall survival at 200 day | 200 days | |
Secondary | Disease Free Survival at 2 Years | Disease Free Survival at 2 years | 2 years | |
Secondary | Disease Progression | Incidence of relapse / disease progression | 3 years | |
Secondary | Incidence of Acute GVHD | Participants who develop acute GVHD | 100 days | |
Secondary | Incidence of Chronic GVHD | Participants who develop chronic GVHD | 3 years | |
Secondary | Median Time to ANC>500/mm3 | Time in days | 3 years | |
Secondary | Median Time to Platelets>20K/mm3 | Time in days | 3 years | |
Secondary | Severity of Acute GVHD | Grade I | 100 days | |
Secondary | Severity of Acute GVHD | Grade II | 100 days | |
Secondary | Severity of Acute GVHD | Grade III | 100 days | |
Secondary | Severity of Acute GVHD | Grade IV | 100 days | |
Secondary | Severity of Chronic GVHD | Extensive | 3 years | |
Secondary | Severity of Chronic GVHD | Limited | 3 years |
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