Lymphoma, Non-Hodgkin Clinical Trial
Official title:
Haploidentical Stem Cell Transplantation Utilizing T-Cell Depletion as Therapy for Patients With Refractory Hematological Malignancies
Relapsed disease is the most common cause of death in children with hematological
malignancies. Patients who fail high-intensity conventional chemotherapeutic regimens or
relapse after stem cell transplantation have a poor prognosis. Toxicity from multiple
therapies and elevated leukemic/tumor burden usually make these patients ineligible for the
aggressive chemotherapy regimens required for conventional stem cell transplantation.
Alternative options are needed. One type of treatment being explored is called
haploidentical transplant.
Conventional blood or bone marrow stem cell transplant involves destroying the patient's
diseased marrow with radiation or chemotherapy. Healthy marrow from a donor is then infused
into the patient where it migrates to the bone marrow space to begin generating new blood
cells. The best type of donor is a sibling or unrelated donor with an identical immune
system (HLA "match"). However, most patients do not have a matched sibling available and/or
are unable to identify an acceptable unrelated donor through the registries in a timely
manner. In addition, the aggressive treatment required to prepare the body for these types
of transplants can be too toxic for these highly pretreated patients. Therefore doctors are
investigating haploidentical transplant using stem cells from HLA partially matched family
member donors.
Although haploidentical transplant has proven curative in many patients, this procedure has
been hindered by significant complications, primarily regimen-related toxicity including
graft versus host disease (GVHD), and infection due to delayed immune reconstitution. These
can, in part, be due to certain white blood cells in the graft called T cells. GVHD happens
when the donor T cells recognize the patient's (the host) body tissues are different and
attack these cells. Although too many T cells increase the possibility of GVHD, too few may
cause the recipient's immune system to reconstitute slowly or the graft to fail to grow,
leaving the patient at high-risk for infection. However, the presence of T cells in the
graft may offer a positive effect called graft versus malignancy or GVM. With GVM, the donor
T cells recognize the patient's malignant cells as diseased and, in turn, attack these
diseased cells.
For these reasons, a primary focus for researchers is to engineer the graft to provide a T
cell depleted product to reduce the risk of GVHD, yet provide a sufficient number of cells
to facilitate immune reconstitution, graft integrity and GVM.
In this study, patients were given a haploidentical graft engineered to with specific T cell
parameter values using the CliniMACS system. A reduced intensity, preparative regimen was
used to reduce regimen-related toxicity and mortality. The primary goal of this study is to
evaluate overall survival in those who receive this study treatment.
Status | Completed |
Enrollment | 25 |
Est. completion date | February 2009 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 21 Years |
Eligibility |
Inclusion Criteria: Refractory hematological malignancies (chemoresistant relapse or
primary induction failure) including: - Acute lymphoblastic leukemia (ALL), must have isolated or combined bone marrow relapse or primary induction failure. Patients with extramedullary relapse are not eligible unless they have previously received a stem cell transplant - Acute myeloid leukemia (AML) >25% blasts in bone marrow - Secondary AML - Myelodysplastic syndrome (MDS) - Secondary MDS - Chronic myeloid leukemia (CML) - Juvenile myelomonocytic leukemia (JMML) - Paroxysmal nocturnal hemoglobinuria (PNH) - Non-Hodgkin's lymphoma (NHL)* - Hodgkin's Disease (HD)* *Patients with lymphomas must have failed standard non-cross reactive combination salvage chemotherapy with or without radiation therapy followed by autologous stem cell transplant or patients with chemo resistant disease - If patient has had previous stem cell transplant, must not be no earlier than 3 months from previous date of transplant - Patients with shortening fraction greater than or equal to 25% - Patients with creatinine clearance greater than or equal to 40cc/min/1.73m^2 - Patients with FVC greater than or equal to 40% of predicted, or pulse oximetry greater than or equal to 92% on room air - Patients with a performance score (Lansky/Karnofsky) of greater than or equal to 50 - Must have a suitable family member donor that is HIV negative, greater than or equal to 18 years of age available for stem cell donation Exclusion Criteria: - Patients with a known allergy to murine products - (Female Patients) Patient is pregnant - Female Patients) Patient is lactating |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To ask in terms of one-year survival the efficacy of haploidentical stem cell transplantation in children with refractory hematological malignancies. | July 2006 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540340 -
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
|
Phase 1 | |
Recruiting |
NCT04460235 -
Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma
|
Phase 4 | |
Completed |
NCT03484702 -
Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma
|
Phase 2 | |
Completed |
NCT01410630 -
FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
|
||
Active, not recruiting |
NCT05024045 -
Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
|
Phase 1 | |
Completed |
NCT06190457 -
Safety and Efficacy of Intrathecal Rituximab in 16 Children of Stage Ⅲ、ⅣNon-Hodgkin Lymphoma
|
||
Completed |
NCT02369016 -
Phase III Copanlisib in Rituximab-refractory iNHL
|
Phase 3 | |
Recruiting |
NCT01676805 -
Tissue Collection for Studies of Lymph Cancer
|
||
Terminated |
NCT00916045 -
Pilot Study of Unrelated Cord Blood Transplantation
|
Phase 2 | |
Terminated |
NCT00529503 -
A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
|
Phase 2 | |
Withdrawn |
NCT00538096 -
A Phase I Study to Evaluate Safety, Tolerability in Adults With Lymphoma
|
Phase 1 | |
Completed |
NCT00534989 -
Use of FDG PET as Predictor of Residual Disease and Subsequent Relapse in Patients With NHL and HD Undergoing HDC and ASCT
|
N/A | |
Withdrawn |
NCT00319332 -
A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen
|
Phase 3 | |
Completed |
NCT00156013 -
Clofarabine for Relapsed or Refractory T-Cell or B-Cell Non-Hodgkin Lymphoma (NHL)
|
Phase 1/Phase 2 | |
Completed |
NCT00141297 -
A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer
|
Phase 1 | |
Completed |
NCT00322842 -
Treatment With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients
|
Phase 2 | |
Completed |
NCT02509039 -
A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL)
|
Phase 1 | |
Completed |
NCT01573000 -
A Randomized Study of Iodine-131 Anti-b1 Antibody Versus Anti-b1 Antibody in Chemotherapy-relapsed/Refractory Low-grade or Transformed Low-grade Non-Hodgkin's Lymphoma (NHL)
|
Phase 2 | |
Completed |
NCT00268203 -
Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma
|
Phase 2 | |
Completed |
NCT03289182 -
An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)
|