Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
36 participants
INTERVENTIONAL
2001-10-31
2015-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow
NCT00003838
NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders
NCT00053989
Umbilical Cord Blood (UCB) Transplant, Fludarabine, Melphalan, and Anti-thymocyte Globulin (ATG) in Treating Patients With Hematologic Cancer
NCT00827099
Non-Myeloablative Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Treatment of Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia
NCT00513175
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
NCT01093586
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cladribine + melphalan
Cladribine + melphalan conditioning
Nonmyeloablative Allogeneic Transplant
Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day
TLI
Total lymphoid irradiation conditioning
Nonmyeloablative Allogeneic Transplant
Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nonmyeloablative Allogeneic Transplant
Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day
Nonmyeloablative Allogeneic Transplant
Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age \< 55 and LVEF \< 45% or creatinine clearance \< 60 ml/min
3. Ability to cover the cost of the transplant, necessary medications, and transportation/housing.
4. Caregiver must be available while outpatient
Guidelines for Cladribine-Melphalan-based conditioning:
* Bone Marrow Failure States Severe Aplastic Anemia (relapsed following immunosuppressive therapy) Paroxysmal Nocturnal Hemoglobinuria (poor prognostic features or hemosiderosis)
* AML (first CR except for t(15;17), inv16, t(8,21); second CR; relapse failing second induction attempt)
* ALL (first CR with at least one poor prognostic feature; second or greater CR; relapse failing reinduction attempt)
* MDS (RAEB, RAEBiT, CMMoL)
* CML (chronic phase; accelerated phase; blast phase following reinduction attempt; 2nd chronic or accelerated phase following gleevec therapy
* Hodgkin's lymphoma (first or greater relapse)
* Non-Hodgkin's Lymphoma
* Aggressive Histology (includes T Cell NHL) Incomplete response to induction Second CR Sensitive or refractory relapse
* Indolent Histology Second or greater relapse
* Mantle Cell Lymphoma (any Stage - must have received induction chemotherapy)
* Multiple Myeloma (10% residual plasmacytosis following anthracycline-based chemotherapy or residual disease following autologous transplant)
* Waldenstrom Macroglobulinemia (must have failed either purine analogue-based chemotherapy (Fludara or 2CdA) or standard CVP therapy; hyperviscosity or cytopenias)
Guidelines for total lymphoid irradiation-based conditioning
* MDS (RA, RARS)
* CLL (Rai stage III or IV - must have received at least two different treatment regimens in the past)
* Breast Cancer (symptomatic metastatic disease, who have failed standard chemotherapy)
* Renal Cell Cancer (metastatic disease at multiple sites)
* Malignant Melanoma (metastatic disease at multiple sites)
* Sarcoma (all subtypes presently, unresectable metastatic disease)
* Ovarian Cancer (stage III or IV, platinum insensitive disease, i.e. progression within 6 months of initial platinum chemotherapy)
* Thymoma (unresectable disease)
Exclusion Criteria
2. Current or past history of invasive mycotic infection
3. Breast Feeding
18 Years
72 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Scripps Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffrey W. Andrey, M.D.
Role: PRINCIPAL_INVESTIGATOR
Scripps Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Scripps Green Hospital
La Jolla, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB#13-6255
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.