Study Summary
This trial is testing the safety and effectiveness of a new cancer drug.
Eligible Conditions
- Relapsed Acute Lymphoblastic Leukemia
- Refractory Acute Lymphoblastic Leukemia
- Acute Lymphoblastic Leukemia (ALL)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 24 months
24 months
Overall response rate (ORR)
Day 30
Dose-limiting Toxicity (DLT)
Trial Safety
Safety Progress
Side Effects for
Palbociclib + Fulvestrant
61%Neutropenia
38%Fatigue
29%Nausea
27%White blood cell count decreased
26%Anaemia
21%Headache
21%Neutrophil count decreased
20%Leukopenia
19%Diarrhoea
17%Constipation
15%Hot flush
15%Alopecia
14%Vomiting
13%Cough
13%Decreased appetite
13%Arthralgia
12%Thrombocytopenia
12%Stomatitis
11%Dizziness
11%Back pain
11%Dyspnoea
10%Pain in extremity
9%Rash
9%Oropharyngeal pain
8%Pyrexia
8%Platelet count decreased
8%Insomnia
7%Dyspepsia
7%Nasopharyngitis
7%Myalgia
7%Asthenia
7%Oedema peripheral
6%Abdominal pain
6%Dysgeusia
6%Injection site pain
6%Aspartate aminotransferase increased
6%Dry mouth
6%Musculoskeletal pain
6%Muscle spasms
6%Pruritus
6%Upper respiratory tract infection
6%Epistaxis
5%Depression
4%Anxiety
4%Pain
3%Musculoskeletal chest pain
3%Abdominal pain upper
2%Chest pain
1%Pulmonary embolism
1%Disease progression
Trial Design
2 Treatment Groups
Cohort 1 -(without Ph+ / Ph like mutation)
1 of 2
Cohort 2-(Ph+ / Ph like ALL subtypes):
1 of 2
Experimental Treatment
22 Total Participants · 2 Treatment Groups
Primary Treatment: Palbociclib · No Placebo Group · Phase 1
Cohort 1 -(without Ph+ / Ph like mutation)Experimental Group · 4 Interventions: Doxorubicin, Bortezomib, Palbociclib, Dexamethasone · Intervention Types: Drug, Drug, Drug, Drug
Cohort 2-(Ph+ / Ph like ALL subtypes):Experimental Group · 4 Interventions: Doxorubicin, Bortezomib, Palbociclib, Dexamethasone · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
FDA approved
Bortezomib
FDA approved
Palbociclib
FDA approved
Dexamethasone
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,170 Previous Clinical Trials
35,768,261 Total Patients Enrolled
6 Trials studying Acute Lymphoblastic Leukemia (ALL)
10,158 Patients Enrolled for Acute Lymphoblastic Leukemia (ALL)
Tanja Andrea GruberLead Sponsor
Tanja A Gruber, MDPrincipal InvestigatorStanford Universiy
Eligibility Criteria
Age < 65 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have had a hematopoietic stem cell transplant (HSCT) and have relapsed.
You have relapsed or refractory to chemotherapy as defined by ≥ 5% leukemic blasts in the bone marrow or flow cytometry confirmed leukemic blasts in the peripheral blood.
Subjects who relapse on therapy other than standard ALL maintenance must have fully recovered from the acute toxic effects of all prior anti cancer therapy, defined as resolution of all such toxicities to ≤ Grade 2 or lower per the inclusion/exclusion criteria.
Subjects who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study.
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Conditions
Cancer Related
Treatments