Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Reduced Intensity Stem Cell Transplantation for Advanced Chronic Lymphocytic Leukemia Followed by Vaccination With Lethally Irradiated Autologous Tumor Cells Admixed With Granulocyte Macrophage-colony Stimulating Factor Secreting K562 Cells
The purpose of this research study is to assess the safety and immune activity of a vaccine made from the participant's own cancer cells, when administered after a reduced intensity transplant. In recent years, researchers at Dana-Farber Cancer Institute have discovered that vaccines made from a patients's own cancer cells, that have been engineered in the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer.
- This study can be divided into four phases: 1) Screening; 2) Reduced intensity
transplant phase; 3) Vaccinations (cycle 1 and cycle 2:each cycle lasts 7 weeks) and 4)
Vaccine completion.
- Screening Phase: After signing the consent form, participants will be asked to undergo
some screening tests and procedures to find out if they are eligible to participate in
the study. These tests and procedures are likely to be part of regular cancer care and
may be done even if the patient does not take part in the research study. It is
important to note that if insufficient numbers of the participant's leukemia cells to
generate vaccine were collected on the CLL collection and banking study (DF/HCC study
06-200), then they will not be eligible to participate in this study.
- Allogeneic reduced intensity stem cell transplant phase: The transplant phase of the
study will begin when the participant is admitted to the hospital to receive
chemotherapy and stem cell transplant. The minimum duration of hospitalization for the
procedure is approximately 8 days. Undergoing transplant involves the following
procedures and treatments: Central intravenous catheter; chemotherapy; medications to
prevent graft versus host disease (GVHD); medication to prevent infections; physical
exams; blood tests and bone marrow biopsy and aspirate.
- Vaccination Phase: Vaccinations will be given in two cycles, of seven weeks each, that
are identical with the exception of when they are administered. Cycle 1 vaccination will
begin approximately one month after the stem cells have been infused, provided there is
no significant evidence of GVHD. Cycle 2 vaccination will be being approximately one
month after discontinuing tacrolimus, provided there is no evidence of severe acute or
chronic GVHD. The vaccine will be given 6 times over a period of two months. The
participant will receive vaccination shots once weekly for 3 vaccines and then every
other week for 3 vaccines.
- Skin biopsies will be done after the first and after the fifth vaccinations. Current
status of the participants CLL will be assessed to determine how the disease has
responded to transplant and vaccination. These tests include analysis of bone marrow and
blood tests.
- Vaccine completion phase: After one cycle of vaccination is completed, the participant
will return to the outpatient clinic monthly for check-ups for 6 visits, to monitor the
effects of the vaccine.
- Since this trial involves the use of genetically modified cells, it is recommended that
participants on this trial undergo annual checkups for at least 20 years, in order to
monitor for long term effects of the vaccination treatment.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Enrolling by invitation |
NCT01804686 -
A Long-term Extension Study of PCI-32765 (Ibrutinib)
|
Phase 3 | |
Completed |
NCT02057185 -
Occupational Status and Hematological Disease
|
||
Active, not recruiting |
NCT04240704 -
Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL
|
Phase 1 | |
Recruiting |
NCT03676504 -
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03280160 -
Protocol GELLC-7: Ibrutinib Followed by Ibrutinib Consolidation in Combination With Ofatumumab
|
Phase 2 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT00038025 -
A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies
|
Phase 2 | |
Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
Terminated |
NCT02231853 -
Phase I/II Trial of Early Infusion of Rapidly-generated Multivirus Specific T Cells (MVST) to Prevent Post Transplant Viral Infections
|
Phase 1 | |
Recruiting |
NCT05417165 -
Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia
|
Phase 2 | |
Recruiting |
NCT04028531 -
Understanding Chronic Lymphocytic Leukemia
|
||
Completed |
NCT00001637 -
Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
|
Phase 2 | |
Completed |
NCT02910583 -
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
|
Phase 2 | |
Completed |
NCT01527045 -
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
Recruiting |
NCT04679012 -
Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation
|
Phase 2 | |
Recruiting |
NCT05405309 -
RP-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05023980 -
A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
|
Phase 3 | |
Recruiting |
NCT04553692 -
Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers
|
Phase 1 | |
Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|