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Vinca alkaloids

Marqibo for Acute Lymphoblastic Leukemia

Phase 1
Waitlist Available
Research Sponsored by Therapeutic Advances in Childhood Leukemia Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approx. 8 weeks
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat relapsed acute lymphoblastic leukemia.

Eligible Conditions
  • Acute Lymphoblastic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx. 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and approx. 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability
Secondary outcome measures
Therapeutic procedure

Side effects data

From 2016 Phase 2 trial • 175 Patients • NCT01055314
36%
Febrile neutropenia
31%
Death NOS
30%
Diarrhea
22%
Pain
21%
Hyperglycemia
16%
Anorexia
16%
Infections and infestations - Other, specify
16%
Alanine aminotransferase increased
14%
Hypokalemia
13%
Nausea
11%
Hyponatremia
10%
Weight loss
9%
Anemia
9%
Aspartate aminotransferase increased
9%
Vomiting
9%
Mucositis oral
9%
Constipation
9%
Dehydration
9%
Hypophosphatemia
8%
Platelet count decreased
8%
Sepsis
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Catheter related infection
7%
Colitis
7%
Abdominal pain
6%
White blood cell decreased
6%
Hypotension
6%
GGT increased
6%
Hypocalcemia
6%
Urinary retention
6%
Hypoalbuminemia
6%
Fever
5%
Typhlitis
5%
Anxiety
5%
Neutrophil count decreased
5%
Urinary tract infection
4%
Peripheral motor neuropathy
4%
Enterocolitis
4%
Lipase increased
4%
Pleural effusion
4%
Serum amylase increased
4%
Skin infection
4%
Epistaxis
4%
Urinary tract obstruction
3%
Syncope
3%
Lymphocyte count decreased
3%
Wound infection
3%
Blood bilirubin increased
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Upper gastrointestinal hemorrhage
2%
Vulval infection
2%
Depressed level of consciousness
2%
Thromboembolic event
2%
Stridor
2%
Allergic reaction
2%
Back pain
2%
Lung infection
2%
Urticaria
2%
Acute kidney injury
2%
Muscle weakness lower limb
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Pain in extremity
2%
Peripheral sensory neuropathy
2%
Proctitis
2%
Skin ulceration
2%
Apnea
2%
Stoma site infection
2%
Tumor pain
2%
Left ventricular systolic dysfunction
2%
Pancreatitis
2%
Portal hypertension
2%
Rectal hemorrhage
2%
Creatinine increased
2%
Enterocolitis infectious
2%
Hyperkalemia
2%
Investigations - Other, specify
2%
Abdominal distension
1%
Soft tissue infection
1%
Vascular disorders - Other, specify
1%
Anaphylaxis
1%
Seizure
1%
Anal hemorrhage
1%
Ascites
1%
Esophageal pain
1%
Heart failure
1%
Hepatobiliary disorders - Other, specify
1%
Penile pain
1%
Gastrointestinal disorders - Other, specify
1%
Bone marrow hypocellular
1%
Delirium
1%
Sore throat
1%
Tracheitis
1%
Vasovagal reaction
1%
Menorrhagia
1%
Anal mucositis
1%
Fracture
1%
Hydrocephalus
1%
Device related infection
1%
Tooth infection
1%
Gastric ulcer
1%
Sinusitis
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Pharyngitis
1%
Pyramidal tract syndrome
1%
Anal ulcer
1%
Depression
1%
Ejection fraction decreased
1%
Rash maculo-papular
1%
Pruritus
1%
Myositis
1%
Nail infection
1%
Pain of skin
1%
Pleuritic pain
1%
Pneumonitis
1%
Pneumothorax
1%
Postoperative hemorrhage
1%
Renal and urinary disorders - Other, specify
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Salivary duct inflammation
1%
Small intestine infection
1%
Alkaline phosphatase increased
1%
Appendicitis
1%
Spinal fracture
1%
Disseminated intravascular coagulation
1%
Ear and labyrinth disorders - Other, specify
1%
Endocrine disorders - Other, specify
1%
Esophageal stenosis
1%
Esophagitis
1%
Gastric hemorrhage
1%
Gum infection
1%
Tumor lysis syndrome
1%
Upper respiratory infection
1%
Hypertriglyceridemia
1%
Hypoxia
1%
Ileus
1%
INR increased
1%
Laryngeal edema
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral hemorrhage
1%
Oral pain
1%
Pulmonary edema
1%
Rectal fistula
1%
Rectal pain
1%
Respiratory failure
1%
Bladder spasm
1%
Chest wall pain
1%
Confusion
1%
Congenital, familial and genetic disorders - Other, specify
1%
CPK increased
1%
Dizziness
1%
Encephalopathy
1%
Eye disorders - Other, specify
1%
Generalized muscle weakness
1%
Hoarseness
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Insomnia
1%
Irregular menstruation
1%
Irritability
1%
Joint range of motion decreased cervical spine
1%
Kyphosis
1%
Lethargy
1%
Headache
1%
Laryngeal mucositis
1%
Pelvic pain
1%
Esophageal infection
1%
Abdominal infection
1%
Acidosis
1%
Anal fistula
1%
Fall
1%
Fatigue
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort C: Marqibo and maintenance regimenExperimental Treatment1 Intervention
Marqibo®: given by intravenous (IV) infusion on day 1 Dexamethasone orally twice daily on days 1-5 Methotrexate: given orally on days 1 and 8 Mercaptopurine: given orally daily on days 1-13
Group II: Cohort B: Marqibo and lower intensity UK ALL R3 backboneExperimental Treatment1 Intervention
Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. Dexamethasone orally twice daily on days 1-5 and 15-19. PEG-asparaginase: given as an injection into the muscle on days 3 and 17. Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8.
Group III: Cohort A: Marqibo and UK ALL R3 backboneExperimental Treatment1 Intervention
Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. Dexamethasone orally twice daily on days 1-5 and 15-19. Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2. PEG-asparaginase: given as an injection into the muscle on says 3 and 17. Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
FDA approved

Find a Location

Who is running the clinical trial?

Spectrum Pharmaceuticals, IncIndustry Sponsor
82 Previous Clinical Trials
8,130 Total Patients Enrolled
Therapeutic Advances in Childhood Leukemia ConsortiumLead Sponsor
20 Previous Clinical Trials
641 Total Patients Enrolled
~4 spots leftby Jun 2025
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