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LP-168 for Waldenstrom Macroglobulinemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Waldenstrom Macroglobulinemia+6 MoreLP-168 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see if it is safe and works well.

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • Mantle Cell Lymphoma
  • Waldenstrom Macroglobulinemia
  • Chronic Lymphocytic Leukemia
  • Follicular Lymphoma
  • Hairy Cell Leukemia
  • Marginal Zone Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
D2C7-IT
1
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Study Objectives

3 Primary · 3 Secondary · Reporting Duration: At Cycle 1: Day 1, Day 2, Day 8, Day 9, Day 15, Day 22, Day 28; At Cycle 3: Day 28; At Cycle 6 Day 28; (each cycle is 28 days

Day 28
Pyruvate Kinase
Month 24
Duration of Response (DOR)
Maximum Tolerated Dose (MTD)
Objective Response Rate (ORR)
Progression-Free Survival (PFS)
Recommended Phase 2 dose (RP2D)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
NBF-006
1
D2C7-IT
1
GFH009

Trial Design

2 Treatment Groups

Dose Expansion Phase
1 of 2
Dose Escalation Phase
1 of 2

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: LP-168 · No Placebo Group · Phase 1

Dose Expansion Phase
Drug
Experimental Group · 1 Intervention: LP-168 · Intervention Types: Drug
Dose Escalation Phase
Drug
Experimental Group · 1 Intervention: LP-168 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at cycle 1: day 1, day 2, day 8, day 9, day 15, day 22, day 28; at cycle 3: day 28; at cycle 6 day 28; (each cycle is 28 days

Who is running the clinical trial?

Newave Pharmaceutical IncLead Sponsor
3 Previous Clinical Trials
210 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Minor grades of B-cell lymphomas which include follicular Grade 1, 2, or 3A, marginal zone, or small lymphocytic lymphoma.
The activated partial thromboplastin time (APTT) and prothrombin time (PT) should not exceed 1.5 × the upper limit of the normal range.
The text suggests that the patient has a creatinine clearance of at least 60 milliliters per minute using either the 24-hour CrCl method or the Cockcroft-Gault formula.
AST and ALT levels must be less than 1.5 times the upper limit of normal; bilirubin levels must be less than 1.5 times the upper limit of normal, except for people with Gilbert's Syndrome, who may have a bilirubin level greater than 1.5 times the upper limit of normal, if discussed with the Investigator and Medical Monitor.
The patient has a platelet count of 50,000 or more per microliter or a platelet count of 20,000 or more per microliter if the thrombocytopenia is clearly due to CLL disease under study
People with B-cell malignancies such as WM, FL, MCL, MZL, DLBCL, HCL, CLL, SLL can take part in this study, as long as their cancer is classified as such by the 2016 updated WHO classification
therapy not necessary The absolute neutrophil count (ANC) is ≥1000/uL, so therapy is not necessary.
IF a subject has an ANC of less than 1000/uL and the bone marrow is heavily infiltrated with underlying disease (approximately 60% or more), the subject MAY use growth factor to achieve the ANC eligibility criteria, per discussion between the Investigator and the Medical Monitor.
If the hemoglobin level is below 8.0, a transfusion may be necessary to raise the level.
References

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