Venetoclax Basket Trial for High Risk Hematologic Malignancies

NCT ID: NCT05292664

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-29
• Study Completion Date: 2028-07-02

Brief Summary

This trial is evaluating the safety and tolerability of venetoclax with chemotherapy in pediatric and young adult patients with hematologic malignancies, including myelodysplastic syndrome (MDS), acute myeloid leukemia derived from myelodysplastic syndrome (MDS/AML), and acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL).

The names of the study drugs involved in this study are below. Please note this is a list for the study as a whole, participants will receive drugs according to disease cohort.

• Venetoclax
• Azacitidine
• Cytarabine
• Methotrexate
• Hydrocortisone
• Leucovorin
• Dexamethasone
• Vincristine
• Doxorubicin
• Dexrazoxane
• Calaspargase pegol
• Hydrocortisone

Detailed Description

This is an investigator-initiated open-label multi-institutional phase I study of venetoclax combination therapy in both myeloid and lymphoid hematologic malignancies. This study is designed as a basket trial with three separate cohorts. All cohorts include a dose finding portion (Part I) followed by a dose expansion at the Recommended Phase II dose (RP2D, Part II).

This research study is looking to learn more about how Venetoclax works and aims to determine the safest, highest possible dose that can be combined with standard of care chemotherapies. Because of this, not everyone who participates in this research study may receive the same dose of the study drug. The dose participants receive will depend on the number of participants who have been enrolled in the study previously and how well the doses have been tolerated.

Study procedures include screening for eligibility as well as study treatment visits including evaluations and follow up visits.

• Cohort A: Patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia arising from MDS (MDS/AML) or treatment-related myeloid neoplasms (tMDS/AML). It is expected that up to 18 people will participate in Part 1 (Dose Determination) and an additional 14-20 people will participate in Part 2 (Dose Expansion) of this cohort.
• Cohort B: Patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia arising from MDS (MDS/AML) or treatment-related myeloid neoplasms (tMDS/AML) with an underlying genetic condition that increases their risk of experiencing toxic side effects of chemotherapy. It is expected that up to 18 people will participate in Part 1 (Dose Determination) and an additional 6 people will participate in Part 2 (Dose Expansion) of this cohort.
• Cohort C: Patients with relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL). It is expected that up to 18 people will participate in Part 1 (Dose Determination) and an additional 12 people will participate in Part 2 (Dose Expansion) of this cohort.

This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved Venetoclax for use in children. However, Venetoclax is FDA-approved as a treatment for certain types of leukemia in adults. It is actively being studied in children and adults with other types of cancer. Information from these research studies has suggested that venetoclax may also be effective in treating participants with MDS or leukemia, including MDS or leukemia that did not respond to standard treatment or that has come back after standard treatment. The survival of cancer cells is controlled by proteins within the cancer cell. One of these proteins is called BCL-2. The study drug, venetoclax, blocks this protein and is thought to reduce cell survival in some cancer cells.

Conditions

Myelodysplastic Syndromes, de Novo; Myelodysplastic Syndromes, Secondary; Myelodysplastic Syndromes, Previously Treated; Treatment-Related Acute Myeloid Leukemia; Therapy-Related Myelodysplastic Syndrome; Acute Lymphoblastic Leukemia, in Relapse; Acute Lymphoblastic Leukemia With Failed Remission; Lymphoblastic Lymphoma, in Relapse; Lymphoblastic Lymphoma, Refractory; Acute Leukemia of Ambiguous Lineage in Relapse; Acute Leukemia of Ambiguous Lineage

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

For Part 1, participants will receive:

• Patients with myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML). It is expected that up to 18 people will participate in Part 1 (Dose Determination) and an additional 14-20 people will participate in Part 2 (Dose Expansion) of this cohort Treatment cycle is approximately 28 days for up to 4 cycles

• Venetoclax-once daily on predetermined days per protocol
• Azacitidine-once daily on predetermined days per protocol

• Cytarabine, Methotrexate, Hydrocortisone and Leucovorin will be given only if MDS/leukemia cells are detected in spinal fluid per determination of treating physician

Group Type: EXPERIMENTAL

Venetoclax

Intervention Type: DRUG

Tablet taken orally

Azacitidine

Intervention Type: DRUG

Taken intravenously

Cytarabine

Intervention Type: DRUG

Lumbar Puncture

Methotrexate

Intervention Type: DRUG

Lumbar Puncture

Hydrocortisone

Intervention Type: DRUG

Lumbar Puncture

Leucovorin

Intervention Type: DRUG

Taken Orally or intravenously

Cohort B

Patients with myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) with an underlying genetic condition that increases their risk for developing treatment-related toxicities. It is expected that up to 18 people will participate in Part 1 (Dose Determination) and an additional 6 people will participate in Part 2 (Dose Expansion) of this cohort.

• Venetoclax-once daily on predetermined days per protocol
• Azacitidine-once daily on predetermined days per protocol
• Cytarabine, Methotrexate, Hydrocortisone and Leucovorin will be given only if MDS/leukemia cells are detected in spinal fluid per determination of treating physician

Group Type: EXPERIMENTAL

Venetoclax

Intervention Type: DRUG

Tablet taken orally

Azacitidine

Intervention Type: DRUG

Taken intravenously

Cytarabine

Intervention Type: DRUG

Lumbar Puncture

Methotrexate

Intervention Type: DRUG

Lumbar Puncture

Hydrocortisone

Intervention Type: DRUG

Lumbar Puncture

Leucovorin

Intervention Type: DRUG

Taken Orally or intravenously

Cohort C

Patients with relapsed/refractory acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LBL) or acute leuekmai of ambiguous lineage. It is expected that up to 18 people will participate in Part 1 (Dose Determination) and an additional 12 people will participate in Part 2 (Dose Expansion) of this cohort.

Cohort C: Treatment cycle is approximately 32 days for one cycle and will be a single treatment cycle:

Dosage, duration and timings as outlined in protocol.

• Venetoclax
• Dexamethasone
• Vincristine
• Doxorubicin
• Dexrazoxane
• Calaspargase pegol

---Short acting Erwinia preparations (recombinant or native Erwinia asparaginase) may be used for participants with known pegaspargase or calaspargase pegol allergy

• Cytarabine
• Methotrexate
• Hydrocortisone
• Leucovorin- *Cytarabine, Methotrexate, Hydrocortisone and Leucovorin may be given more frequently if leukemia/lymphoma cells are detected in spinal fluid),

Group Type: EXPERIMENTAL

Venetoclax

Intervention Type: DRUG

Tablet taken orally

Cytarabine

Intervention Type: DRUG

Lumbar Puncture

Methotrexate

Intervention Type: DRUG

Lumbar Puncture

Hydrocortisone

Intervention Type: DRUG

Lumbar Puncture

Leucovorin

Intervention Type: DRUG

Taken Orally or intravenously

Dexamethasone

Intervention Type: DRUG

Taken Orally or intravenously

Vincristine

Intervention Type: DRUG

Taken intravenously

Doxorubicin

Intervention Type: DRUG

Taken intravenously

Dexrazoxane

Intervention Type: DRUG

Taken intravenously

Calaspargase Pegol

Intervention Type: DRUG

Taken intravenously

Erwinia asparaginase

Intervention Type: DRUG

Given as intramuscular injection

Interventions

Venetoclax

Tablet taken orally

Intervention Type: DRUG

Azacitidine

Taken intravenously

Intervention Type: DRUG

Cytarabine

Lumbar Puncture

Intervention Type: DRUG

Methotrexate

Lumbar Puncture

Intervention Type: DRUG

Hydrocortisone

Lumbar Puncture

Intervention Type: DRUG

Leucovorin

Taken Orally or intravenously

Intervention Type: DRUG

Dexamethasone

Taken Orally or intravenously

Intervention Type: DRUG

Vincristine

Taken intravenously

Intervention Type: DRUG

Doxorubicin

Taken intravenously

Intervention Type: DRUG

Dexrazoxane

Taken intravenously

Intervention Type: DRUG

Calaspargase Pegol

Taken intravenously

Intervention Type: DRUG

Erwinia asparaginase

Given as intramuscular injection

Intervention Type: DRUG

Other Intervention Names

Venclexta; Vidaza; Ara-C; Arabinosylcytosine; Amethopterin; Methotrexate Sodium; MTX; Cortisone; Hydrocortisone Sodium Succinate; Hydrocortisone Sodium Phosphate; Calcium Leucovorin,; Citrovorum Factor; Folinic Acid; dexamethasone sodium phosphate; dexamethasone acetate; Vincristine Sulfate; LCR; VCR; Adriamycin; Rubex; Zinecard; Asparlas; Rylze or native Erwinia asparaginase

Eligibility Criteria

Inclusion Criteria

• MDS, AML arising from MDS (MDS/AML), therapy related myeloid neoplasm (tMDS/AML) meeting at least one of the following criteria:

• MDS with excess blasts (>10%)
• MDS with blasts <10% with high-risk features
• MDS refractory to initial treatment
• Relapsed MDS
• MDS/AML: May be newly diagnosed or relapsed/refractory disease.
• Therapy related myeloid neoplasm (tMDS/AML): May be initial or relapsed/refractory disease.

• Note: MDS or MDS/AML may be derived from a germline predisposition to myeloid malignancy as long as that condition does not confer increased toxicity to treatment.
• Age ≤ 40 years of age, except the following subjects that must be <18 years to enroll

• Subjects with MDS/AML that have not received prior therapy
• Subjects enrolled onto Dose level -2.
• Lansky/Karnofsky performance status ≥ 50%
• Participants must have fully recovered from the acute toxic effects of all and meet all of the following criteria:

• Myelosuppressive chemotherapy: 14 days, or 5 half-lifes (whichever is shorter) must have elapsed since the completion of myelosuppressive therapy. Individuals may have received any of the following medications without a "wash-out" period

• Standard maintenance therapy: dexamethasone/prednisone, vincristine, 6MP, low dose methotrexate)
• Hydroxyurea
• Intrathecal chemotherapy with methotrexate, hydrocortisone and/or cytarabine.
• Radiation therapy (XRT):

• Total Body Irradiation (TBI) or cranial radiation therapy: Must have been completed more than 90 days prior to study entry
• XRT for chloroma does not require a washout period.
• Palliative XRT does not require a washout
• Small molecule inhibitors (BCR-ABL or FLT3 inhibitors, for example): 7 days, or 5 half-lifes, whichever is shorter) must have elapsed since the completion of therapy. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.
• Immunotherapy: At least 30 days after the administration of any type of immunotherapy, including, but not limited to, tumor vaccines, chimeric antigen receptor (CAR) therapy, other immune effector cell therapy and checkpoint inhibitors.
• Monoclonal antibodies: At least 3 half-lives of the antibody
• Prior hematopoietic stem cell transplant (HSCT):

• Allogeneic HSCT > 90 days of study entry
• No evidence of graft-versus-host-disease (GVHD)
• Adequate organ function, as defined by

• Serum alanine aminotransferase (ALT) ≤5X upper limit of normal (ULN)
• Direct bilirubin ≤ 3X
• Ejection fraction ≥ 50% or shortening fraction of ≥ 24% on screening echocardiogram.
• Female participants of childbearing potential must have a negative urine or serum HCG prior to study entry and at the start of therapy. All females of childbearing potential must refrain from breastfeeding during study participation, and all male and females of childbearing potential must agree to use an effective form of contraception (abstinence, hormonal, or barrier) prior to study entry, for duration of participation, and for a minimum of 30 days following the last dose of treatment.

• MDS, MDS/AML, therapy related myeloid neoplasm (tMDS/AML) that is derived from the following germline disorders:

• Dyskeratosis Congenita or associated telomeropathies
• Fanconi Anemia
• Nijmegen Breakage
• Other related disorders with high risk of toxicity may be eligible for this cohort after discussion with the Sponsor-Investigator.
• And meets at least one the following disease characteristics:

• MDS with excess blasts (>10%)
• MDS with blasts <10% with high-risk features
• MDS refractory to initial treatment
• Relapsed MDS
• MDS/AML: May be newly diagnosed or relapsed/refractory disease.
• Therapy related myeloid neoplasm (tMDS/AML): May be initial or relapsed/refractory disease.
• Age ≤ 40 years of age
• Lansky/Karnofsky performance status ≥ 50%
• Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and meet all of the following criteria:

• Myelosuppressive chemotherapy: 14 days, or 5 half-lifes (which ever is shorter) must have elapsed since the completion of myelosuppressive therapy. Individuals may have received any of the following medications without a "wash-out" period

• Standard maintenance therapy: dexamethasone/prednisone, vincristine, 6MP, low dose methotrexate
• Hydroxyurea
• Intrathecal chemotherapy with methotrexate, hydrocortisone and/or cytarabine.
• Radiation therapy (XRT):

• Total Body Irradiation (TBI) or cranial radiation therapy: Must have been completed more than 90 days prior to study entry
• XRT for chloroma does not require a washout period.
• Palliative XRT does not require a washout
• Small molecule inhibitors (BCR-ABL or FLT3 inhibitors, for example): 7 days, or 5 half-lifes, whichever is shorter) must have elapsed since the completion of therapy. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.
• Immunotherapy: At least 30 days after the administration of any type of immunotherapy, including, but not limited to, tumor vaccines, chimeric antigen receptor (CAR) therapy, other immune effector cell therapy and checkpoint inhibitors.
• Monoclonal antibodies: At least 3 half-lives of the antibody
• Prior hematopoietic stem cell transplant (HSCT): Must meet all of the following conditions:

• Allogeneic HSCT > 90 days of study entry
• No evidence of graft-versus-host-disease (GVHD)
• Adequate organ function, as defined by

• Serum alanine aminotransferase (ALT) ≤5X upper limit of normal (ULN)
• Direct bilirubin ≤ 3X upper limit of normal for age and institution.
• Ejection fraction ≥ 50% or shortening fraction of ≥ 24% on screening echocardiogram.
• Because of the teratogenic effects of venetoclax on developing fetuses, female participants of childbearing potential must have a negative urine or serum HCG prior to study entry and at the start of therapy. All females of childbearing potential must refrain from breastfeeding during study participation, and all male and females of childbearing potential must agree to use an effective form of contraception (abstinence, hormonal, or barrier) prior to study entry, for duration of participation, and for a minimum of 30 days following the last dose of treatment.

• Part I: B-cell or T-cell acute lymphoblastic leukemia (ALL), mixed phenotype acute lymphoblastic leukemia (MPAL) or lymphoblastic lymphoma (LBL) in first or greater relapse or refractory to at least 1 prior remission induction attempt.

• For ALL/MPAL: Bone marrow involvement ≥ 5% by aspirate morphology or ≥ 1% assessable by flow cytometry or validated molecular minimal residual disease (MRD) testing
• For LBL: Radiographically detectable mass or lymph node involvement
• Part II: Histologically confirmed diagnosis of one of the following:

• T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) in first or greater relapse or refractory to at least 1 prior remission induction attempt.

• For T-ALL: Bone marrow involvement ≥ 5% by aspirate morphology or ≥ 1% assessable by morphology, flow cytometry or validated MRD testing
• For T-LBL (biopsy proven at current or prior relapse): Radiographically detectable mass or lymph node involvement OR
• Relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) with bone marrow involvement ≥1% (assessable by morphology, flow cytometry or validated MRD testing) and at least one of the following characteristics:

• First relapse with adverse biologic determinants as described below:

• KMT2A rearrangement
• Low hypodiploidy, defined as ≤ 40 chromosomes
• t(17;19)
• IKZF1 deletion (without targetable ABL1 fusion)
• Ph-like ALL (without targetable ABL1 fusion)
• Other biologic determinants with adverse prognosis in discussion with the Sponsor-Investigator
• Early first bone marrow relapse occurring <36 months from initial diagnosis
• Primary refractory ALL that has failed 1 prior induction attempt
• Age: ≥ 1 and ≤ 21 years of age
• Lansky/Karnofsky performance status ≥ 50%
• Participants must have fully recovered from the acute toxic effects of all prior and meet all of the following criteria:

• Myelosuppressive chemotherapy: 14 days, or 5 half-lives, whichever is shorter, must have elapsed since the completion of myelosuppressive therapy. Individuals may have received any of the following medications without a "wash-out" period:

• Standard maintenance therapy: dexamethasone/prednisone, vincristine, 6MP, low dose methotrexate
• Hydroxyurea
• Intrathecal chemotherapy with methotrexate, hydrocortisone and/or cytarabine.
• Radiation therapy (XRT):

• Total Body Irradiation (TBI) or cranial radiation therapy: Must have been completed more than 90 days prior to study entry
• XRT for chloroma does not require a washout period.
• Palliative XRT does not require a washout
• Small molecule inhibitors (BCR-ABL or FLT3 inhibitors, for example): 7 days, or 5 half-lifes, whichever is shorter) must have elapsed since the completion of therapy. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.
• Immunotherapy: At least 30 days after the administration of any type of immunotherapy, including, but not limited to, tumor vaccines, chimeric antigen receptor (CAR) therapy, other immune effector cell therapy and checkpoint inhibitors.
• Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody
• Prior hematopoietic stem cell transplant (HSCT): Patients who have received HSCT are eligible, but must meet all of the following conditions:

• Allogeneic HSCT > 90 days of study entry
• No evidence of graft-versus-host-disease (GVHD)
• Adequate organ function, as defined by the following laboratory values:

• Serum alanine aminotransferase (ALT) ≤5X upper limit of normal (ULN), unless deemed secondary to leukemic involvement in discussion with site PI.)
• Direct bilirubin ≤ 3X upper limit of normal for age and institution.
• Serum amylase ≤ 3X institutional ULN .
• Cardiac function as defined as below:

• Ejection fraction ≥ 50% or shortening fraction of ≥ 24% on screening echocardiogram.
• Maximum prior cumulative doxorubicin dose ≤ 360 mg/m2 or equivalent
• Because of the teratogenic effects of venetoclax on developing fetuses, female participants of childbearing potential must have a negative urine or serum HCG prior to study entry and at the start of therapy. All females of childbearing potential must refrain from breastfeeding during study participation, and all male and females of childbearing potential must agree to use an effective non-hormonal form of contraception (abstinence, barrier) prior to study entry, for duration of participation, and for a minimum of 3 months following the last dose of treatment (as calaspargase pegol can render hormonal contraceptives ineffective).

Exclusion Criteria

• Use of strong or moderate CYP3A inhibitors/inducers within 3 days of study entry
• Individuals who have had a stem cell transplant and are still receiving treatment for GVHD or GVHD prophylaxis, or who have evidence of acute GVHD
• Individuals with known active hepatitis; baseline testing not required.
• Patients with systemic infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.
• Patients known to have human immunodeficiency virus (HIV) infection; baseline testing for HIV is not required.
• Pregnant or nursing women are excluded.
• Individuals with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

• Use of strong or moderate CYP3A inhibitors/inducers within 3 days of study entry
• Individuals who have had a stem cell transplant and are still receiving treatment for GVHD or GVHD prophylaxis, or who have evidence of acute GVHD
• Individuals with known active hepatitis; baseline testing not required.
• Patients with systemic infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.
• Patients known to have human immunodeficiency virus (HIV) infection; baseline testing for HIV is not required.
• Pregnant or nursing women are excluded.
• Individuals with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

• Use of strong or moderate CYP3A inhibitors/inducers within 3 days of study entry
• Individuals who have had a stem cell transplant and are still receiving treatment for GVHD or GVHD prophylaxis, or who have evidence of acute GVHD, or who are less than 90 days from stem cell infusion
• Individuals with known active hepatitis; baseline testing not required.
• Patients with systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.
• Patients known to have human immunodeficiency virus (HIV) infection; baseline testing for HIV is not required.
• Pregnant or nursing women are excluded
• Individuals with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
• Individuals with a history of allergic reactions to any of the agents being used in this trial, with the exception of pegaspargase or calaspargase pegol. Participants with a history of allergy to pegylated formulation of asparasginase are allowed on study but should receive commercial supply of asparaginase Erwinia chrysanthemi (Erwinaze), crisantaspase (Erwinase), or asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) instead of calaspargase pegol (see Sections 6.2.6 and 6.2.7). Individuals with a history of allergy to Erwinaze, Erwinase or Rylaze are excluded from the study.
• History of asparaginase-associated pancreatitis.
• Known, active and propagating deep venous thrombus (DVT).
• Individuals with isolated CNS or testicular relapse.
• Presence of surface immunoglobulin by flow cytometry and/or known t(8;14), t(2;8), or t(8;22).
• Individuals with a history of a different malignancy are ineligible except for the following circumstances:

• Individuals are eligible if they have been disease-free for at least 1 year and are deemed by the investigator to be at low risk for recurrence of that malignancy.
• Individuals with the following cancers are eligible if diagnosed and treated within the past year: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

Servier

INDUSTRY

Sponsor Role: collaborator

Children's Cancer Research Fund

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: collaborator

Gateway for Cancer Research

OTHER

Sponsor Role: collaborator

Andrew E. Place, MD

OTHER

Sponsor Role: lead

Responsible Party

Andrew E. Place, MD

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrew E Place, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

University of California San Francisco-Benioff Children's Hospital

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's Healthcare of Atlanta at Arthur M. Blank Hospital

Atlanta, Georgia, United States

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

21-757

Identifier Type: -

Identifier Source: org_study_id