Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Acute Disease

Neoplasms by Histologic Type

Hematologic Diseases

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Analgesics

Antirheumatic Agents

Micronutrients

Etoposide

Cytarabine

Venetoclax

Mitoxantrone

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Carboplatin

Doxorubicin

Liposomal doxorubicin

Azacitidine

Decitabine

Topotecan

Daunorubicin

Etoposide phosphate

Thioguanine

Asparaginase

Idarubicin

Midostaurin

Sorafenib

Ivosidenib

Clofarabine

Cladribine

Iodine

Cadexomer iodine

Gemtuzumab

Iomab-B in conjunction with a Reduced Intensity Conditioning (RIC) regimen containing Fludarabine and low-dose Total Body Irradiation (TBI) prior to allogeneic HCT

Defined as Investigator's choice of salvage chemotherapy with any combination of the following agents: Azacitidine (not allowed as a single agent), Carboplatin, Cladribine, Clofarabine, Cyclophosphamide, Cytarabine, Daunorubicin, Decitabine (not allowed as a single agent with the exception of patients with documented TP53 mutations who have not previously received 10-day regimens of single agent decitabine), Doxorubicin, Enasidenib, Etoposide, Fludarabine, Gemtuzumab ozogamicin, Idarubicin, Ivosidenib (for subjects with IDH1 mutation), L-Asparaginase, Midostaurin (for FLT3 mutant or FLT3-ITD subjects only, not allowed as single agent), Mitoxantrone, Sorafenib (for FLT3 mutant or FLT3-ITD subjects only, not allowed as single agent), Thioguanine, Topotecan, Venetoclax (in combination with a hypomethylating agent). Chemotherapy agents not listed above may be administered after providing clinical justification and receiving medical monitor approval prior to initiation of treatment.

Iomab-B

Conventional Care

Avinash Desai, MD

The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care in patients with Active, Relapsed or Refractory Acute Myeloid Leukemia (AML).

SIERRA is a pivotal Phase 3 randomized controlled study of Iomab-B in Relapsed or Refractory AML patients. The SIERRA trial has a primary endpoint of durable Complete Remission (dCR) at six months and a secondary endpoint of overall survival following randomization to Iomab-B, as well as Event-Free Survival. Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially safer and more efficacious manner than intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning.

Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia

A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplant Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia (AML)

Defined as CR or CRp lasting 180 days or more from time of initial CR or CRp is documented with evidence of subsequent relapse

Duration of time from randomization to the date of induction treatment failure (ITF), relapse or death

Actinium Pharmaceuticals

Immune System Diseases

Infections

Heart and Blood Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Myeloproliferative Disorders

Leukemia, Prolymphocytic

Primary Myelofibrosis

Burkitt Lymphoma

Anemia, Refractory, with Excess of Blasts

Leukemia, Plasma Cell

Leukemia, Biphenotypic, Acute

Anemia

Anemia, Refractory

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Bone Marrow Diseases

Precancerous Conditions

Leukemia, B-Cell

Chronic Disease

Lymphoma, B-Cell

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Multiple Myeloma

Neoplasms, Plasma Cell

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Lymphosarcoma

Peripheral T-cell Lymphoma

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Follicular Lymphoma

Marginal Zone Lymphoma

Chronic Myeloproliferative Disorders

Acute Leukemia of Ambiguous Lineage

Myelodysplastic Syndrome With Excess Blasts

Plasma Cell Leukemia

B-cell Lymphoma

Central Nervous System Depressants

Other Dietary Supplements

Mycophenolic Acid

Sirolimus

Benzocaine

Allopurinol

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Enzyme Inhibitors

Clotrimazole

Miconazole

Antifungal Agents

Antioxidants

Protective Agents

Tannic Acid

On day 0, a target dose of 5 x 106 CD34 cells/kg will be infused.

Peripheral Blood Stem Cell Transplant

300 mg/day from day -7 to day 0. Allopurinol 150mg/m2/day for pediatric participants.

Allopurinol 300 MG

30 mg/m2 IV over 1 hour. Administered on day -6 to day -2.

Administered as a 2 hour IV infusion on day -6, +3, and +4.

On day 0, a target dose of 3 x 108 nucleated cells/kg recipient weight will be infused.

Bone Marrow Cell Transplant

The dose of TBI will be 200 cGy given in a single fraction on day -1.

Total Body Irradiation

All participants begin +5 to day +100.

Loading dose on day +5 of 5 mg/m2/day orally once (max dose of 8 mg).

Maintenance dose 2.5 mg/m2 orally daily to maintain a level of 8-12 ng/ml (max dose of 4 mg).

Sirolimus Pill

All patients begin day +5 through day +35.

3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 doses. In obese patients (\>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patients will receive MMF at the dose of 15 mg/kg/dose (maximum of 1 gram per dose) every 8 hours.

Mycophenolate Mofetil

Mark Juckett

This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.

Allo HSCT Using RIC and PTCy for Hematological Diseases

Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

Number of participants with GVHD grades 2-4 after one year post transplant.

Number of participants with chronic GVHD after one year post transplant.

Number of participants that experienced relapse within 100 days of treatment.

Observe overall participant survival at Day 100 and at 1 and 3 years

Number of participants with transplant related mortality within 12 months of treatment.

Masonic Cancer Center, University of Minnesota

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia	NCT02665065	Acute Myeloid L... Leukemia, Acute... Myeloid Leukemi... Leukemia, Myelo... Acute Myelogeno... Leukemia, Acute... Myelogenous Leu... AML Bone Marrow Tra...	Iomab-B Conventional Ca... HCT	55 Years -	Actinium Pharmaceuticals
Allo HSCT Using RIC and PTCy for Hematological Diseases	NCT05805605	Acute Myelogeno... Acute Lymphocyt... Biphenotypic Ac... Undifferentiate... Prolymphocytic ... Chronic Myeloge... Plasma Cell Leu... Myelodysplastic... Leukemia, Myelo... Myelodysplastic... Burkitt Lymphom... Relapsed T-Cell... Relapsed Chroni... Small Lymphocyt... Marginal Zone L... Follicular Lymp... Myeloproliferat... Myelofibrosis	Peripheral Bloo... Allopurinol 300... Fludarabine Cyclophosphamid... Bone Marrow Cel... Total Body Irra... Sirolimus Pill Mycophenolate M...	- 75 Years	Masonic Cancer Center, University of Minnesota

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