- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05088356
Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
Phase 1 Trial for Patients With Advanced Hematologic Malignancies Undergoing Reduced Intensity Allogeneic HCT With a T-cell Depleted Graft With Infusion of Conventional T-cells and Regulatory T-cells
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: Fludarabine
- Device: CliniMACS CD34 Reagent System
- Drug: Tacrolimus
- Drug: Cyclophosphamide
- Drug: Plerixafor
- Drug: Filgrastim granulocyte colony-stimulating factor (G-CSF) or equivalent
- Drug: Purified regulatory T-cells (Treg) plus CD34+ HSPC
- Drug: Melphalan
- Drug: Thiotepa
- Drug: Mycophenolate Mofetil (MMF)
- Drug: Ruxolitinib
Detailed Description
The objectives for the study are listed below:
Primary Objectives
*Determine the safety, and feasibility of administration of several dose combinations of conventional T-cells (Tcon) and regulatory T-cells (Treg) in subjects undergoing allogeneic hematopoietic cell transplantation (HCT) with related/unrelated HLA-matched or mismatched donors, or haploidentical donors with reduced intensity conditioning preparative regimen.
Secondary Objectives
- To determine the GVHD-free relapse-free survival (GRFS) post-HCT
- To determine the overall survival (OS) post-HCT
- To measure the incidence and severity of acute and chronic GVHD
Exploratory Objectives
- To measure the incidence of serious infections
- To measure the incidence and timing of engraftment
- To measure T cell immunity reconstitution parameters
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Lindsay Danley
- Phone Number: 650-736-0304
- Email: lindsmd@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94304
- Recruiting
- Stanford University
-
Principal Investigator:
- Everett Meyer, MD, PhD
-
Contact:
- Lindsay Danley
- Phone Number: 650-736-0304
- Email: lindsmd@stanford.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Recipient Inclusion Criteria
a. Patients with the following diseases that are histopathologically-confirmed are eligible
- Acute myeloid, lymphoid, or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) or beyond first complete remission (CR1) without the presence of minimal residual disease
- Acute myeloid, leukemia, or mixed phenotype leukemia that is either:
- Not in morphologic CR with bone marrow infiltration by leukemic blasts of ≤10%, or
- In morphologic CR with evidence of minimal residual disease positivity by either multiparametric flow cytometric analysis or by a nucleic acid-based technique
- Primary refractory acute myeloid, lymphoid, or mixed phenotype leukemia
- Chronic myelogenous leukemia (accelerated, blast or second chronic phase)
- Myelodysplastic syndromes
Myeloproliferative syndromes b. Match to the patient as follows: a. For Arm A1 (CLOSED):
- Availability of a 8/8 or 7/8 HLA-matched donor (related or unrelated) defined by Class I (HLA-A, -B, -C) serologic typing (or higher resolution) and Class II (HLA-DRB1) molecular typing.
- If the donor is a 7/8 HLA-match, the mismatch must be a permissive allelic mismatch as assessed by an independent HLA and transplantation expert. b. For Arm A1 and Arm A3:
Availability of a 8/8 HLA-matched donor (related or unrelated) defined by Class I (HLA-A, -B, -C) serologic typing (or higher resolution) and Class II (HLA-DRB1) molecular typing.
c. For Arm B (CLOSED):
- Availability of a haploidentical donor who is a ≥ 4/8 but <7/8 match at HLA-A, -B, -C, and -DRB1 (typed using DNA-based high-resolution methods), with at most one mismatch per locus d. For Arm C1 (CLOSED) and C2:
Availability of a 8/8 HLA matched donor (related or unrelated) defined by Class I (HLA-A, B, C) serologic typing (or higher resolution) and Class II (HLA DRB1) molecular typing.
c. Age ≥ 18 and ≤75 years old at the time of enrollment. d. Left ventricular ejection fraction (LVEF) ≥ 45% e. Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 50% f. Calculated creatinine clearance ≥ 50 mL/min or creatinine < 2.0 mg/dL g. SGPT and SGOT ≤ 3 x ULN, unless elevated secondary to disease Total bilirubin ≤ 2 x ULN (patients with Gilbert's syndrome may be included at the discretion of the PI or where hemolysis has been excluded h. Negative serum or urine beta-HCG test in females of childbearing potential within 3 weeks of registration i. Karnofsky performance status ≥ 70%
Donor Inclusion Criteria
- Age ≥ 18 and ≤ 75 years of age
- Karnofsky performance status of ≥ 70% defined by institutional standards
- Seronegative for HIV-1 RNA PCR; HIV 1 and HIV 2 ab (antibody); HTLV-1 and HTLV-2 ab; PCR+ or sAg (surface antigen) hepatitis B ; or PCR or sAg negative for hepatitis C; negative for the Treponema palladum antibody Syphillis screen; and negative for HIV-1 and hepatitis C by nucleic acid testing (NAT) within 30 days of apheresis collection.
- In the case that T palladum antibody tests are positive, donors must:
Be evaluated and show no evidence of syphilis infection of any stage by physical exam and history, or Have completed effective antibiotic therapy to treat syphilis, or Have a documented negative non-treponemal test (such as RPR) or in the case of a positive non-treponemal test must be evaluated by an infectious disease expert to evaluate for alternative causes of test positivity and confirm no evidence of active syphilitic disease e. Match to the patient as follows:
Arm A1(CLOSED):
• Must be a related or unrelated, 8/8 or 7/8-HLA match to recipient at HLAA, -B, -C, and -DRB1. If 7/8 HLA-matched, must be with permissive allelic HLA mismatch as assessed by an independent HLA and transplantation expert.
Arm A2 and Arm A3:
• Must be a related or unrelated, 8/8 HLA match to recipient at HLA A, B, C, and DRB1
Arm B (CLOSED):
- Must be a haploidentical donor who is ≥ 4/8 but < 7/8 match at HLA-A, -B, -C, and -DRB1, with at most one mismatch per locus.
Arm C1 (CLOSED) and Arm C2:
- Must be a related or unrelated 7/8 HLA matched to recipient at HLA A, B, C, DRB1 or -DQB1
f. Must be willing to donate PBSC for up two consecutive days g. Female donors of child-bearing potential must have a negative serum or urine beta HCG test within 3 weeks of mobilization h. Capable of undergoing leukapheresis, have adequate venous access, and be willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate i. Agreeable to 2nd donation of PBPC (or bone marrow harvest) in the event of graft failure j. The donor or legal guardian greater than 18 years of age, capable of signing an IRB approved consent form. k. Meets other criteria for donation as specified by standard NMDP guidelines (NMDP donors) or institutional standards (non-NMDP donors) l. Donors not meeting federal eligibility criterion, may nonetheless be included if either apply as follows per 21 CFR § 1271.65:
- The donor is a first-degree or second-degree blood relative of the recipient, or
- Documented urgent medical need (DUMN), meaning no comparable human cell product is available and the recipient is likely to suffer death or serious morbidity without the human cell product, as attested by the Investigator or sub-investigator
Exclusion Criteria:
Recipient Exclusion Criteria
Seropositive for any of the following:
HIV antibodies; hepatitis B surface antigen (sAg); hepatitis C antibodies
- Patients deemed candidates for fully myeloablative preparative conditioning regimens
d. Candidate for autologous transplant e. Hepatitis B or C with SGPT or SGOT > 3 x ULN f. HIV-positive g. Active uncontrolled bacterial, viral or fungal infection, defined as currently taking antimicrobial therapy and progression of clinical symptoms. h. Uncontrolled CNS disease involvement i. Pregnant or a lactating female j. Positive serum or urine beta-HCG test in females of childbearing potential within 3 weeks of registration k. Psychosocial circumstances that preclude the patient being able to go through transplant or participate responsibly in follow-up care l. Known allergy or hypersensitivity to, or intolerance of, tacrolimus m. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor determined by either:
- A positive crossmatch of any titer; or
- The presence of anti-donor HLA antibody to any HLA locus n. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment o. Concurrent malignancies or active disease within 1 year, except nonmelanomatous skin cancers that have been curatively resected
Donor Exclusion Criteria
- Evidence of active infection
- Seropositive for HIV-1 or-2, HTLV-1 or -2
- Medical, physical, or psychological reason that would place the donor at increased risk for complications from growth factor or leukapheresis
- Lactating female
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A1: Matched related/matched unrelated donor transplantation (closed)
Subjects will receive reduced intensity preparative chemotherapy conditioning for a matched related/ unrelated donor transplant:.
All enrolled subjects will receive GVHD prophylaxis with single-agent tacrolimus. |
Fludarabine (160 mg/m2)
Other Names:
4-6ng/mL
Other Names:
Dose 0.24 mg/kg, manufactured by Genzyme
Other Names:
Single-use vials contain either 300 mcg or 480 mcg filgrastim at a fill volume of 1.0 mL or 1.6 mL
Other Names:
Purified regulatory T-cells (Treg) plus CD34+ hematopoietic progenitor cells ("CD34+ HSPC"), followed by conventional T-cells (Tcon) Manufactured at SCTT Laboratory, dose 1x10^6 cells/ kg to 3x10^6 cells/kg
Melphalan (50 mg/m2)
Other Names:
|
Experimental: Arm B: Haploidentical transplantation (closed)
Subjects without an identified matched related or matched unrelated donor will receive a haploidentical transplantation with reduced intensity preparative conditioning: -. Fludarabine (160 mg/m2)
Patients will receive GVHD prophylaxis with post-transplant cyclophosphamide and tacrolimus. |
Fludarabine (160 mg/m2)
Other Names:
The CliniMACS® CD34 Reagent System is a medical device that is used in vitro to select and enrich specific cell populations is manufactured by Miltenyi Biotec
4-6ng/mL
Other Names:
40mg/kg
Other Names:
Dose 0.24 mg/kg, manufactured by Genzyme
Other Names:
Single-use vials contain either 300 mcg or 480 mcg filgrastim at a fill volume of 1.0 mL or 1.6 mL
Other Names:
Purified regulatory T-cells (Treg) plus CD34+ hematopoietic progenitor cells ("CD34+ HSPC"), followed by conventional T-cells (Tcon) Manufactured at SCTT Laboratory, dose 1x10^6 cells/ kg to 3x10^6 cells/kg
Melphalan (50 mg/m2)
Other Names:
|
Experimental: Arm A2: Fully matched (8/8) related/unrelated donor transplantation
Subjects will receive reduced intensity preparative chemotherapy conditioning for a matched related/ unrelated donor transplant:
All enrolled subjects will receive GVHD prophylaxis with single-agent tacrolimus. |
Fludarabine (160 mg/m2)
Other Names:
4-6ng/mL
Other Names:
Dose 0.24 mg/kg, manufactured by Genzyme
Other Names:
Single-use vials contain either 300 mcg or 480 mcg filgrastim at a fill volume of 1.0 mL or 1.6 mL
Other Names:
Purified regulatory T-cells (Treg) plus CD34+ hematopoietic progenitor cells ("CD34+ HSPC"), followed by conventional T-cells (Tcon) Manufactured at SCTT Laboratory, dose 1x10^6 cells/ kg to 3x10^6 cells/kg
Thiotepa 10 mg/kg
Other Names:
|
Experimental: Arm A3: Fully (8/8) matched related/unrelated donor transplantation
Subjects will receive reduced intensity preparative chemotherapy conditioning for a matched related/ unrelated donor transplant:
All enrolled subjects will receive GVHD prophylaxis with single-agent tacrolimus. |
Fludarabine (160 mg/m2)
Other Names:
4-6ng/mL
Other Names:
Dose 0.24 mg/kg, manufactured by Genzyme
Other Names:
Single-use vials contain either 300 mcg or 480 mcg filgrastim at a fill volume of 1.0 mL or 1.6 mL
Other Names:
Purified regulatory T-cells (Treg) plus CD34+ hematopoietic progenitor cells ("CD34+ HSPC"), followed by conventional T-cells (Tcon) Manufactured at SCTT Laboratory, dose 1x10^6 cells/ kg to 3x10^6 cells/kg
Thiotepa 10 mg/kg
Other Names:
|
Experimental: Arm C1:7/8 mismatched related/unrelated donor transplantation (closed)
Subjects will receive reduced intensity preparative chemotherapy conditioning for a matched related/ unrelated donor transplant:
|
Fludarabine (160 mg/m2)
Other Names:
4-6ng/mL
Other Names:
Dose 0.24 mg/kg, manufactured by Genzyme
Other Names:
Single-use vials contain either 300 mcg or 480 mcg filgrastim at a fill volume of 1.0 mL or 1.6 mL
Other Names:
Purified regulatory T-cells (Treg) plus CD34+ hematopoietic progenitor cells ("CD34+ HSPC"), followed by conventional T-cells (Tcon) Manufactured at SCTT Laboratory, dose 1x10^6 cells/ kg to 3x10^6 cells/kg
Thiotepa 10 mg/kg
Other Names:
MMF 1000 mg BID
Other Names:
|
Experimental: Arm C2: 7/8 mismatched related/unrelated donor transplantation
Subjects will receive reduced intensity preparative chemotherapy conditioning for a matched related/ unrelated donor transplant:
All enrolled subjects will receive GVHD prophylaxis with tacrolimus and ruxolitinib. |
Fludarabine (160 mg/m2)
Other Names:
4-6ng/mL
Other Names:
Dose 0.24 mg/kg, manufactured by Genzyme
Other Names:
Single-use vials contain either 300 mcg or 480 mcg filgrastim at a fill volume of 1.0 mL or 1.6 mL
Other Names:
Purified regulatory T-cells (Treg) plus CD34+ hematopoietic progenitor cells ("CD34+ HSPC"), followed by conventional T-cells (Tcon) Manufactured at SCTT Laboratory, dose 1x10^6 cells/ kg to 3x10^6 cells/kg
Thiotepa 10 mg/kg
Other Names:
Ruxolitinib 5 mg BID
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the GVHD-free relapse-free survival (GRFS) post-HCT ( Arm-A)
Time Frame: 12 months
|
Clinical effect will be assessed as graft vs host disease (GVHD)-free relapse free survival (GRFS), GVHD-free is defined as no GVHD symptoms, and relapse free survival is defined as survival at 12 months without relapse.
The outcome will be measured in Arm A only.
|
12 months
|
Determine the overall survival (OS) post-HCT ( Arm-B)
Time Frame: 2 years
|
Overall survival is measured as number of participants alive.
Alive at the time of last observation will be censored.
|
2 years
|
Incidence of Grade III-IV acute GVHD
Time Frame: At baseline, day +30, 60, 90, 180, year 1 and year 2
|
Acute GVHD will be staged and graded per Mount Sinai Acute GvHD International Consortium (MAGIC) Standardization criteria.
|
At baseline, day +30, 60, 90, 180, year 1 and year 2
|
The incidence and timing of primary graft failure
Time Frame: 2 years from the Day 0 (day of CD34+ peripheral blood stem cell infusion
|
Primary graft failure is defined as being alive with donor CD3 chimerism <5% at day +30 after transplant without recovery of neutrophils (i.e.
without achieving an absolute neutrophil count [ANC] ≥ 500/mm3 for 3 consecutive days) at Day+28
|
2 years from the Day 0 (day of CD34+ peripheral blood stem cell infusion
|
Donor CD3 chimerism at Day+60 post-HCT
Time Frame: 2 years from the Day 0 (day of CD34+ peripheral blood stem cell infusion)
|
Defined as a percentage on donor CD3 cells chimerism at day +60 after transplantation.
|
2 years from the Day 0 (day of CD34+ peripheral blood stem cell infusion)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GVHD-relapse-free survival
Time Frame: 12 months
|
Clinical effect will be assessed as graft vs host disease (GVHD)-free relapse free survival (GRFS), GVHD-free is defined as no GVHD grade 3 and 4, and relapse free survival is defined as survival at 12 months without relapse.
|
12 months
|
Overall survival
Time Frame: 12 months
|
Overall survival is measured as number of participants alive.
Alive at the time of last observation will be censored.
|
12 months
|
Secondary graft failure
Time Frame: from Day 0 through 100 days
|
Secondary graft failure (defined by donor CD3 chimerism <5% at day +30 after transplant) and neutrophil engraftment followed by subsequent decline in ANC < 500/mm3 unresponsive to growth factor therapy, by Day +100
|
from Day 0 through 100 days
|
Treatment-emergent adverse events (TEAs)
Time Frame: from Day 0 through 100 days
|
TEAEs will be categorized by the System Organ Class and preferred term and will be graded according to the CTCAE version 5.0
|
from Day 0 through 100 days
|
Acute GVHD (all grades)
Time Frame: from Day 0 through 100 days
|
Acute GVHD (all grades) will be reported
|
from Day 0 through 100 days
|
Steroid-refractory acute GVHD
Time Frame: within 3-5 days of therapy onset
|
Steroid refractory acute GVHD will be defined as per the EBMT-NIH-CIBMTR Task Force position statement
|
within 3-5 days of therapy onset
|
Non-relapse mortality (NRM)
Time Frame: 12 months
|
Non-relapse mortality is measured as number of participants died without relapse/ recurrent disease.
Subjects without evidence of relapse/progression at last follow-up date or date of death will be censored.
|
12 months
|
Disease-free survival (DFS)
Time Frame: 12 months
|
Overall survival is measured as number of participants alive and in remission.
Alive in remission at the time of last observation will be censored.
|
12 months
|
Chronic GVHD (limited or extensive)
Time Frame: from Day 0 through Year 2
|
Chronic GVHD will be diagnosed per 2014 International NIH Chronic GVHD Diagnosis and Staging Consensus Working Group criteria (Jagasia 2015).
Chronic GVHD scored according to the first day of chronic GVHD onset will be used to calculate cumulative incidence curves.
Subjects will be followed for 2 years from the Day 0 (day of CD34+ peripheral blood stem cell infusion) for estimation of cGVHD incidence.
|
from Day 0 through Year 2
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Neutrophil engraftment
Time Frame: from Day 0 through 100 days
|
Neutrophil engraftment is defined as having an ANC ≥ 500 cells/µL for three consecutive days.
The first of three days will be designated as the day of engraftment.
|
from Day 0 through 100 days
|
Time to Platelet engraftment
Time Frame: from Day 0 through 100 days
|
Platelet engraftment is defined as achieving a platelet count > 20,000 cells/µL for three consecutive days without platelet transfusion in the preceding 7 days.
The first of three days will be designated as the day of engraftment.
|
from Day 0 through 100 days
|
Incidence of serious infections (grade 2 and greater)
Time Frame: from Day 0 through 100 days
|
Incidence of serious infections will be measured as event of infections that led to hospitalization or death or required antibiotic treatment.
Infections will be graded according to the CTCAE version 5.0
|
from Day 0 through 100 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Everett Meyer, MD,PhD, Stanford Universiy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms by Site
- Disease Attributes
- Bone Marrow Diseases
- Hematologic Diseases
- Chronic Disease
- Neoplasms
- Myelodysplastic Syndromes
- Hematologic Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Myeloproliferative Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Myeloablative Agonists
- Anti-Bacterial Agents
- Adjuvants, Immunologic
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Cyclophosphamide
- Lenograstim
- Melphalan
- Fludarabine
- Fludarabine phosphate
- Tacrolimus
- Mycophenolic Acid
- Thiotepa
- Plerixafor
- Alkylating Agents
Other Study ID Numbers
- IRB-60439
- BMT372 (Other Identifier: Stanford)
- NCI-2021-12228 (Other Identifier: NCI Trial ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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