T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts (MOHEL)
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ClinicalTrials.gov Identifier: NCT00368355 |
Recruitment Status :
Completed
First Posted : August 24, 2006
Results First Posted : January 21, 2020
Last Update Posted : January 21, 2020
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Subjects are being asked to participate in this study because treatment of their disease requires them to receive a stem cell transplant. Stem cells or "mother" cells are the source of normal blood cells and lead to recovery of blood counts after bone marrow transplantation (BMT). Unfortunately, there is not a perfectly matched stem cell donor (like a sister or brother) and the subject's disease is considered rapidly progressive and does not permit enough time to identify another donor (like someone from a registry list that is not their relative). We have, however, identified a close relative of the subject's whose stem cells are not a perfect match, but can be used. However, with this type of donor, there is typically an increased risk of developing graft-versus-host disease (GVHD), a high rate of transplant failure, and a longer delay in the recovery of the immune system.
GVHD is a serious and sometimes fatal side effect of stem cell transplant. GVHD occurs when the new donor cells (graft) recognizes that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs, primarily the skin, liver, and intestines. The number of occurrences and harshness of severe GVHD depends on several factors, including the degree of genetic differences between the donor and recipient, the intensity of the pre-treatment conditioning regimen, the quantity of transplanted cells, and the recipient's age. In recipients of mismatched family member or matched unrelated donor stem cell transplants, there is a greater risk of GVHD so that 70-90% of recipients of unchanged marrow will develop severe GVHD which could include symptoms such as marked diarrhea, liver failure, or even death.
In an effort to lower the occurrences and severity of graft-versus-host disease in patients and to lower the rate of transplant failure, we would like to specially treat the donor's blood cells to remove cells that are most likely to attack the patient's tissues. This will occur in combination with intense conditioning treatment that the patient will receive before the transplant.
Condition or disease | Intervention/treatment | Phase |
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Acute Lymphoblastic Leukemia Non Hodgkins Lymphoma Myelodysplastic Syndrome Acute Myeloid Leukemia Chronic Myelogenous Leukemia Hemophagocytic Lymphohistiocytosis (HLH) Familial Hemophagocytic Lymphohistiocytosis (FLH) Viral-associated Hemophagocytic Syndrome (VAHS) X-linked Lymphoproliferative Disease (XLP) | Drug: Ara-C Drug: Cyclophosphamide Biological: Campath-1H Radiation: Total Body Irradiation Procedure: Stem Cell Infusion | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | CD-34 Selection for Ex-vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts Receiving Intensive Conditioning |
Study Start Date : | April 2000 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | November 2016 |

Arm | Intervention/treatment |
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Experimental: CLINIMACS Device
Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device
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Drug: Ara-C
day-8 through day-5 3 g/m2 q 12 hours Other Name: cytarabine Drug: Cyclophosphamide day-7 and day-6 45 mg/kg Other Name: Cytoxan Biological: Campath-1H day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS >30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Other Name: Alemtuzumab Radiation: Total Body Irradiation day-4 through day-1 175 cGy x 2 at 24 cGy/min Procedure: Stem Cell Infusion Stem cells are infused on day 0 |
Experimental: ISOLEX Device
Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device
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Drug: Ara-C
day-8 through day-5 3 g/m2 q 12 hours Other Name: cytarabine Drug: Cyclophosphamide day-7 and day-6 45 mg/kg Other Name: Cytoxan Biological: Campath-1H day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS >30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Other Name: Alemtuzumab Radiation: Total Body Irradiation day-4 through day-1 175 cGy x 2 at 24 cGy/min Procedure: Stem Cell Infusion Stem cells are infused on day 0 |
- Engraftment Rate After Transplant [ Time Frame: 28 days ]Percentage of participants with hematopoietic engraftment post-transplant. Engraftment is defined as the first day absolute neutrophil counts exceeded 0.5 X 10^9/ml.
- Early Post BMT Toxicities [ Time Frame: 100 Days ]Number of participants who experience organ failure or severe infections (defined as Grade III/IV by NCI CTC for Adverse Events (CTCAE), version 2.0)
- Severe GVHD Rate [ Time Frame: 100 Days ]Percentage of participants with Grade III/IV acute GVHD. Severe GVHD is defined as Grade III/IV acute GVHD.
- Patients With Acute GVHD [ Time Frame: First 100 Days ]Number of participants with acute GVHD graded by the method of Przepiorka et al, which evaluates skin involvement, lower and upper GI, and liver function (bilirubin), each being graded in stages from 0 to 4, where 0 means no acute GVHD, and 4 is the highest stage of acute GVHD
- Patients With Chronic GVHD [ Time Frame: Up to 1 Year ]Number of participants with chronic GVHD graded by the method of Przepiorka et al, which evaluates skin, joints, oral, ocular, hepatic, esophagus, GI, respiratory, platelet, and musculoskeletal involvement, in stages from 0 to 3.
- Immune Reconstitution [ Time Frame: 1 Year ]To evaluate the effect of T-cell depletion by positive selection for CD34 on immune reconstitution, which will be determined from total lymphocyte count, from T and B cell numbers and from T cell subset analyses.
- Length of Remission in Patients [ Time Frame: 1 Year ]Median length of remission in patients with high risk leukemia treated with myeloablative chemotherapy, radiotherapy and CD34 selected peripheral blood stem cells from haploidentical related donors using Kaplan-Meier method

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Ages Eligible for Study: | up to 55 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
- Lack of suitable conventional donor (i.e. 5/6 or 6/6 related or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor
- Age less than or equal to 55 years of age
- Patients with high risk ALL in CR1 or ALL or high grade (stage III or IV) NHL after first relapse or with primary refractory disease or minimal residual diseases.
- Myelodysplastic syndrome
- Patients with high risk AML in CR1 or after first relapse or with primary refractory disease or minimal residual disease.
- CML
- Hemophagocytic lymphohistiocytosis (HLH), familial hemophagocytic lymphohistiocytosis (FLH), viral-associated hemophagocytic syndrome (VAHS), X-linked lymphoproliferative disease (XLP), Severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T- or NK-cell malignancy
- Donor cells should be collected and frozen before conditioning starts
EXCLUSION CRITERIA:
- Patients with a life expectancy (< / = 6 weeks) limited by diseases other than leukemia
- Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction < 25%)
- Patients with severe renal disease (i.e., creatinine clearance less than 40 cc/1.73 m^2)
- Patients with pre-existing severe restrictive pulmonary disease (FVC less than 40% of predicted)
- Patients with severe hepatic disease (direct bilirubin greater than 3 ug/dl or SGPT (serum glutamic-pyruvic transaminase) greater than 500 ug/dl)
- Patients with severe personality disorder or mental illness
- Patients with a severe infection that on evaluation by the Principal Investigator precludes ablative chemotherapy or successful transplantation
- Patients with documented HIV positivity
'High risk' ALL or AML refers to those acute leukemias identified by the presence of specific biologic features, which predict high likelihood of failure to conventional chemotherapy. As biologic features of high risk disease evolve with improvement of conventional chemotherapy, it is not practical to define this indication with any further specificity. Therefore, high risk AML/ALL will be determined by the primary physician.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368355
United States, Texas | |
Houston Methodist Hospital | |
Houston, Texas, United States, 77030 | |
Texas Children's Hosptial | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Robert A. Krance, MD | Baylor College of Medicine |
Responsible Party: | Robert Krance, Professor, Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00368355 |
Other Study ID Numbers: |
H-8701-MOHEL |
First Posted: | August 24, 2006 Key Record Dates |
Results First Posted: | January 21, 2020 |
Last Update Posted: | January 21, 2020 |
Last Verified: | January 2020 |
haploidenticalstem cell transplant acute lymphoblastic leukemia Non Hodgkins Lymphoma Myelodysplastic Syndrome Acute myeloid leukemia |
Chronic myelogenous leukemia Hemophagocytic lymphohistiocytosis (HLH) Familial hemophagocytic lymphohistiocytosis (FLH) Viral-associated hemophagocytic syndrome (VAHS) X-linked lymphoproliferative disease (XLP) |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Preleukemia Lymphoma, Non-Hodgkin Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic Syndromes Lymphohistiocytosis, Hemophagocytic Lymphoproliferative Disorders Syndrome Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Myeloproliferative Disorders Histiocytosis, Non-Langerhans-Cell Histiocytosis Cytarabine Cyclophosphamide Alemtuzumab Immunosuppressive Agents |