Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT04747912
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inotuzumab ozogamicin — DRUG
    Inotuzumab ozogamicin, sold under the brand name Besponsa, is an anti-cancer drug used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
  • Dasatinib — DRUG
    Dasatinib is a prescription treatment for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
  • Dexamethasone — DRUG
    Dexamethasone is a steroid that prevents the release of substances in the body that cause inflammation.
  • Methotrexate — DRUG
    Methotrexate is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
  • Vincristine — DRUG
    Vincristine, also known as leurocristine and marketed under the brand name Oncovin among others, is a chemotherapy medication used to treat various types of cancer such as acute lymphocytic leukemia, acute myeloid leukemia, Hodgkin's disease, neuroblastoma, and small cell lung cancer among others.
  • Ponatinib — DRUG
    A drug used to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia. It is used in patients whose cancer has the T315I mutation or whose cancer cannot be treated with other tyrosine kinase inhibitors. It is also being studied in the treatment of other types of cancer. Ponatinib blocks BCR-ABL, which may help keep cancer cells from growing and may kill them.
  • Purinethol (6-Mercaptopurine) — DRUG
    Purinethol is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
  • Prednisone — DRUG
    Prednisone is steroid given during chemotherapy treatments.

Study Details

This research study will add an anti-cancer drug (called inotuzumab ozogamicin also known as "InO") to treatment for participants with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Doctors leading this study hope to learn if adding InO to standard induction treatment for Ph+ ALL will lead to quicker, complete molecular remission (where the disease is not detectable even with very sensitive testing techniques). The purpose of this research is to gather information regarding the effectiveness of InO in newly-diagnosed Ph+ ALL patients that have not yet received treatment.

Key Dates

Start date
Mar 2, 2021
Status verified
Jun 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Induction/Consolidation Phase - All Participants
    All participants in this study will receive the same first round of treatment as part of induction/consolidation therapy. This treatment will use inotuzumab ozogamicin combined with anti-cancer drugs. The additional treatment that participants receive after this first round of treatment will vary based on the participant's response to induction therapy. This phase of treatment will last for 60 days. All participants in this arm will receive the following treatment: Treatment Course I (Induction Phase, 28 days): * Dasatinib 140mg daily continuous * Dexamethasone 10mg/m\^2 PO or IV Days 1-7 and Day 15-Day 22 * InO 0.8mg/m2 Day 8; 0.5mg/m2 D15, 0.5mg/m2 Day 22 * Intrathecal methotrexate 15mg Day 1, Day 28 Treatment Course II (Consolidation Phase, 28 days): * Dasatinib 140mg daily continuous * InO: If in CR/CRi 0.5mg/m2 Day 1, Day 8, Day 15; If not in CR/CRi 0.8mg/m2 on Day 1, 0.5mg/m2 Day 8 and Day 15 * Intrathecal methotrexate 15mg Day 1, Day 28
  • Experimental: Maintenance Phase - Participants in CMR (Schema 2 Regimen - Enrollment Completed)
    Participants who no longer show any detectable signs of BCR-ABL1 (a cancer-causing gene) in response to the previous phase of induction/consolidation treatment (also known as being in "complete molecular remission" or CMR). Participants in this arm will receive treatment using dasatinib combined with POMP chemotherapy and intrathecal methotrexate. POMP chemotherapy consists of the drugs 6-Mercaptopurine + Vincristine + Methotrexate + Prednisone.
  • Experimental: Maintenance Phase - Participants Not in CMR (Schema 2 Regimen - Enrollment Completed)
    Participants whose cancer responded to induction/consolidation treatment, but still shows detectable signs of BCR-ABL1 (a cancer-causing gene), so they are not in complete molecular remission (CMR). Participants in this arm will receive treatment using ponatinib combined combined with POMP chemotherapy and intrathecal methotrexate. A single 28-day cycle of inotuzumab will be given after initial 84 days of maintenance treatment if CMR has not been achieved. POMP chemotherapy consists of the drugs 6-Mercaptopurine + Vincristine + Methotrexate + Prednisone.
  • Experimental: Interim/Maintenance Phase - Participants in CMR (Schema 3 Regimen )
    Participants who no longer show any detectable signs of BCR-ABL1 (a cancer-causing gene) in response to the previous phase of induction/consolidation treatment (also known as being in "complete molecular remission" or CMR). Participants in this arm will receive treatment using dasatinib and intrathecal methotrexate.
  • Experimental: Maintenance Phase - Participants Not in CMR (Schema 3 Regimen)
    Participants whose cancer responded to induction/consolidation treatment, but still shows detectable signs of BCR-ABL1 (a cancer-causing gene), so they are not in complete molecular remission. Participants in this arm will receive treatment using ponatinib combined with intrathecal methotrexate. A single 28-day cycle of inotuzumab will be given after initial 84 days of maintenance treatment if CMR has not been achieved.

Primary Outcome Measure

Number of Participants Who Enter Complete Clinical Remission at 60 Days as Defined by Criteria Set By The International Scale [ Time Frame: 60 days ]

Central Contacts

Locations (1)

FacilityCityStateZIP
University of Chicago Medical CenterChicagoIllinois60615

Find similar trials in Chicago, IL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Chicago Medical Center· Chicago, IL

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