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Study to Evaluate the Efficacy of Uproleselan in Combination With Chemotherapy in Chinese Patients With R/R AML

Sponsored by Apollomics Inc.

About this trial

Last updated 3 years ago

Study ID

APL-106-02

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

This bridging study will evaluate the efficacy of uproleselan, a specific E-selectin antagonist, in combination with chemotherapy to treat Chinese relapsed/refractory AML patients, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML

What are the participation requirements?

Yes

Inclusion Criteria

1. ≥18 years and ≤75 years in age

2. AML diagnosed with ≥20% myeloid marrow blasts or peripheral blood blasts per WHO criteria(2008) at the time of initial diagnosis

3. For refractory AML, only cytarabine/daunorubicin(or Idarubicin) as can be applied repeatedly(maximal twice) as induction, no other chemotherapy are allowed to be applied Venatoclax /hypomethylation drug [HMA] can be used before and after chemotherapy.

1. For relapse AML, it must be the first or second relapse, and remain untreated.
2. Certain regimens (Venatoclax/HMA, Venetoclax/LDAC, HMA single agent) and FLT3 inhibitors, tyrosine kinase inhibitors, IDH1/IDH2 inhibitors or similar targeted inhibitors used alone are not considered cytotoxic chemotherapy are allowed.

4. No more than one prior stem cell transplant

5. Has not received the chemotherapy regimen to be used for induction on this trial

6. Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial

No

Exclusion Criteria

1. Patients with acute promyelocytic leukemia

2. Acute leukemia of ambiguous lineage (biphenotypic leukemia)

3. Chronic myeloid leukemia with myeloid blast crisis

4. Active signs or symptoms of CNS involvement by malignancy (No lumbar puncture required)

5. Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.

6. Stem cell transplantation ≤4 months prior to dosing.

7. Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing

8. Inadequate organ function.

9. Abnormal liver function.

10. Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.

11. Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).

12. Uncontrolled acute life-threatening bacterial, viral, or fungal infection.

13. Clinically significant cardiovascular disease.

14. Major surgery within 4 weeks of dosing.

Locations

Location

Status

Recruiting
Recruiting