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Q702 for the Treatment of Patients With Hematologic Malignancies

ConditionsHematopoietic and Lymphatic System NeoplasmHistiocytic SarcomaMalignant HistiocytosisPeripheral T-Cell Lymphoma, Not Otherwise SpecifiedPrimary Cutaneous T-Cell Non-Hodgkin LymphomaRecurrent Chronic Lymphocytic LeukemiaRecurrent Chronic Myelomonocytic LeukemiaRecurrent Follicular LymphomaRecurrent Langerhans Cell HistiocytosisRecurrent Lymphoplasmacytic LymphomaRecurrent Myelodysplastic SyndromeRecurrent MyelofibrosisRecurrent Small Lymphocytic LymphomaRecurrent Waldenstrom MacroglobulinemiaRefractory Chronic Lymphocytic LeukemiaRefractory Chronic Myelomonocytic LeukemiaRefractory Erdheim-Chester DiseaseRefractory Follicular LymphomaRefractory Langerhans Cell HistiocytosisRefractory Lymphoplasmacytic LymphomaRefractory Myelodysplastic SyndromeRefractory MyelofibrosisRefractory Small Lymphocytic LymphomaRefractory Waldenstrom MacroglobulinemiaRosai-Dorfman-Destombes DiseasePrimary Central Nervous System LymphomaRecurrent Blastic Plasmacytoid Dendritic Cell NeoplasmRecurrent Erdheim-Chester DiseaseRecurrent Fibroblastic Reticular Cell SarcomaRecurrent Histiocytic SarcomaRecurrent Interdigitating Dendritic Cell SarcomaRecurrent Rosai-Dorfman-Destombes DiseaseRefractory Blastic Plasmacytoid Dendritic Cell NeoplasmRefractory Fibroblastic Reticular Cell SarcomaRefractory Histiocytic SarcomaRefractory Interdigitating Dendritic Cell SarcomaRefractory Rosai-Dorfman-Destombes Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

This phase I trial tests the safety, side effects, and best dose of Q702 in treating patients with hematologic malignancies. Q702 is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving Q702 may be safe, tolerable and/or effective in treating patients with hematologic malignancies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

PRE-REGISTRATION: Age ≥ 18 years

PRE-REGISTRATION: Not eligible for or have failed therapies with established benefits, at the discretion of the treating physician

Relapsed/refractory patients with Erdheim-Chester disease, Langerhans histiocytosis, histiocytic sarcoma, or other malignant histiocytosis without activating alterations in v-Raf murine sarcoma viral oncogene homolog B (BRAF) or Mitogen-activated protein kinase kinase (MAP2K) oncogenes who have progressed after first line of therapy.

Note: Relapsed is defined as a relapse that occurred after having a response to the last therapy at any point during the treatment. Refractory is no response (stable disease or progressive disease while on therapy) to a given treatment at least after 1 month of being on the given treatment.

Disqualifiers

PRE-REGISTRATION: Myeloproliferative neoplasm (MPN) patients with known active CNS metastases and/or carcinomatous meningitis.

Note: Histiocytosis and lymphoma patients who are on steroids are allowed to enroll

Pregnant persons

Nursing persons

Trial design

Design model

Single group

Treatments tested in this trial

  • Axl/Mer/CSF1R Inhibitor Q702

    Drug

    Given PO

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and urine sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow biopsy and aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy and aspiration

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET scan

  • Survey Administration

    Other intervention

    Ancillary study

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Treatment (Q702)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicity

Up to completion of the first cycle (cycle length= 28 days)

Time frame
Up to 3 years
2

Overall response rate

Exact binomial 95% confidence intervals for the true rate of overall response will be calculated.

Time frame
Up to 3 years

Secondary outcomes

1

Progression free survival (PFS)

PFS is defined as is defined as the time from registration to progression or death due to any cause

Time frame
Up to 3 years
2

Overall survival (OS)

Overall survival (OS) is defined as the time from registration to death due to any cause.

Time frame
Up to 3 years
3

Incidence of adverse events

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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