B-cell acute lymphoblastic leukemia - historical

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the main B-ALL page for current regimens.
Last updated on 2024-07-23:11 regimens on this page
13 variants on this page
 
=Upfront induction therapy=
==Cyclophosphamide, Doxorubicin, L-asparaginase, Vincristine, Prednisolone==
===Regimen===
Study 	Dates of enrollment	Evidence
Takeuchi et al. 2002 (JALSG-ALL93)	1993-1997 	Non-randomized
====Chemotherapy====
*Cyclophosphamide (Cytoxan) 600 mg/m2 IV once on day 29
*Doxorubicin (Adriamycin) 30 mg/m2 IV once per day on days 1 to 3, 8 to 10
*L-Asparaginase 6000 IU/m2 IV once per day on days 29 to 35
*Vincristine (Oncovin) 1.3 mg/m2 (maximum dose of 2 mg) IV bolus once per day on days 1, 8, 15, 22
====Glucocorticoid therapy====
*Prednisolone (Millipred) 40 mg/m2 PO once per day on days 1 to 10
====Supportive therapy====
*G-CSF 200 mcg/m2 IV once per day on days 12 to 26
35-day course
====Subsequent treatment====
*Consolidation I (see paper for details)
===References===
# JALSG-ALL93: Takeuchi J, Kyo T, Naito K, Sao H, Takahashi M, Miyawaki S, Kuriyama K, Ohtake S, Yagasaki F, Murakami H, Asou N, Ino T, Okamoto T, Usui N, Nishimura M, Shinagawa K, Fukushima T, Taguchi H, Morii T, Mizuta S, Akiyama H, Nakamura Y, Ohshima T, Ohno R. Induction therapy by frequent administration of doxorubicin with four other drugs, followed by intensive consolidation and maintenance therapy for adult acute lymphoblastic leukemia: the JALSG-ALL93 study. Leukemia. 2002 Jul;16(7):1259-66. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
==Idarubicin, L-Asparaginase, Vincristine, Prednisone==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Hunault et al. 2004 (GOELAL02)	1994-1998 	Phase 3 (C)	Idarubicin, L-asparaginase, Vincristine, Prednisone; oral prednisone	Did not meet primary endpoint of response rate
Note: This is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.
====Chemotherapy====
*Idarubicin (Idamycin) 5 mg/m2 IV once per day on days 1, 8, 15, 22
*Asparaginase (Elspar) 7500 IU/m2 IV once per day on days 10, 13, 16, 19, 22, 25
*Vincristine (Oncovin) 1.5 mg/m2 IV once per day on days 1, 8, 15, 22
====Glucocorticoid therapy====
*Prednisone (Sterapred) 40 mg/m2 PO or IV once per day on days 1 to 21
35-day course
===References===
#GOELAL02: Hunault M, Harousseau JL, Delain M, Truchan-Graczyk M, Cahn JY, Witz F, Lamy T, Pignon B, Jouet JP, Garidi R, Caillot D, Berthou C, Guyotat D, Sadoun A, Sotto JJ, Lioure B, Casassus P, Solal-Celigny P, Stalnikiewicz L, Audhuy B, Blanchet O, Baranger L, Béné MC, Ifrah N; GOELAMS (Groupe Ouest-Est des Leucémies Airguës et Maladies du Sang) Group. Better outcome of adult acute lymphoblastic leukemia after early genoidentical allogeneic bone marrow transplantation (BMT) than after late high-dose therapy and autologous BMT: a GOELAMS trial. Blood. 2004 Nov 15;104(10):3028-37. Epub 2004 Jul 15. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT00483132
==L-Asparaginase, Vincristine, Prednisone==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Henderson et al. 1979 (CALGB 7113)	1971-1976 	Non-randomized	 	
Gottlieb et al. 1984 (CALGB 7612) 	1976-1980 	Randomized (C)	DOLP 	Lower CR rate
Note: The asparaginase dosing shown here was that after a mid-protocol amendment due to excess toxicity.
====Chemotherapy====
*Asparaginase (Elspar) 500 IU/kg IV once per day on days 16 to 25
*Vincristine (Oncovin) 2 mg IV once per day on days 1, 8, 15
====Glucocorticoid therapy====
*Prednisone (Sterapred) 40 mg/m2/day PO on days 1 to 21, then tapered off over days 22 to 28
28-day course
===References===
# CALGB 7113: Henderson ES, Scharlau C, Cooper MR, Haurani FI, Silver RT, Brunner K, Carey RW, Falkson G, Blom J, Nawabi IV, Levine AS, Bank A, Cuttner J, Cornwell GG 3rd, Henry P, Nissen NI, Wiernik PH, Leone L, Wohl H, Rai K, James GW, Weinberg V, Glidewell O, Holland JF. Combination chemotherapy and radiotherapy for acute lymphocytic leukemia in adults: results of CALGB protocol 7113. Leuk Res. 1979;3(6):395-407. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
# CALGB 7612: Gottlieb AJ, Weinberg V, Ellison RR, Henderson ES, Terebelo H, Rafla S, Cuttner J, Silver RT, Carey RW, Levy RN, Hutchinson JL, Raich P, Cooper MR, Wiernik P, Anderson JR, Holland JF. Efficacy of daunorubicin in the therapy of adult acute lymphocytic leukemia: a prospective randomized trial by Cancer and Leukemia Group B. Blood. 1984 Jul;64(1):267-74. link to original article EuroPMC
==Mercaptopurine & Methotrexate==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Frei et al. 1958 (ALGB 01)	Not reported 	Randomized (E-switch-ic)	6-MP & MTX; alternate dosing	Did not meet endpoints
Frei et al. 1961 (ALGB 03)	1957-1960 	Randomized (E-esc) 	1. 6-MP2. MTX 	Did not meet endpoint of DOR
Note: this is one of the first combination regimens in hematology/oncology.
====Chemotherapy====
*Mercaptopurine (6-MP) 1.5 mg/kg PO twice per day
*Methotrexate (MTX) by the following age-based criteria:
**Less than 2 years old: 1.25 mg PO once per day
**2 to 10 years old: 2.5 mg PO once per day
**Older than 10 years old: 5 mg PO once per day
Continued indefinitely
===References===
# ALGB 01: Frei E 3rd, Holland JF, Schneiderman MA, Pinkel D, Selkirk G, Freireich EJ, Silver RT, Gold GL, Regelson W. A comparative study of two regimens of combination chemotherapy in acute leukemia. Blood. 1958 Dec;13(12):1126-48. link to original article EuroPMC
# ALGB 03: Frei E, Freireich EJ, Gehan E, Pinkel D, Holland JF, Selawry O, Haurani F, Spurr CL, Hayes DM, James GW, Rothberg H, Sodee DB, Rundles RW, Schroeder LR, Hoogstraten B, Wolman IJ, Traggis DG, Cooper T, Gendel BR, Ebaugh F, Taylor R. Studies of Sequential and Combination Antimetabolite Therapy in Acute Leukemia: 6-Mercaptopurine and Methotrexate. Blood. 1961;18(4):431-454. link to original article dosing details in manuscript have been reviewed by our editors
==Prednisolone monotherapy==
===Regimen variant #1===
Study 	Dates of enrollment	Evidence
Shanbrom & Miller 1962	Not reported 	Non-randomized
====Glucocorticoid therapy====
*Prednisolone (Millipred) 50 mg PO once per day on days 1 to 10
10-day course
===Regimen variant #2===
Study 	Dates of enrollment	Evidence
Shanbrom & Miller 1962	Not reported 	Non-randomized
====Glucocorticoid therapy====
*Prednisolone (Millipred) 500 mg PO once per day on days 1 to 10
10-day course
===References===
# Shanbrom E, Miller S. Critical evaluation of massive steroid therapy of acute leukemia. N Engl J Med. 1962 Jun 28;266:1354-8. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
==Prednisone monotherapy==
===Regimen variant #1===
Study 	Dates of enrollment	Evidence
Granville et al. 1958	1955-1956 	Non-randomized
====Glucocorticoid therapy====
*Prednisone (Sterapred) 125 mg PO twice per day on days 1 to 14, then tapered
One course
===Regimen variant #2===
Study 	Dates of enrollment	Evidence
Granville et al. 1958	1955-1956 	Non-randomized
====Glucocorticoid therapy====
*Prednisone (Sterapred) 250 mg PO four times per day on days 1 to 14, then tapered
One course
===References===
# Granville NB, Rubio F Jr, Unugur A, Schulman E, Dameshek W. Treatment of acute leukemia in adults with massive doses of prednisone and prednisolone. N Engl J Med. 1958 Jul 31;259(5):207-13. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
=Late intensification=
==POMP==
POMP: Purinethol (Mercaptopurine), Oncovin (Vincristine), Methotrexate, Prednisone
===Regimen===
Study 	Dates of enrollment	Evidence
Bodey et al. 1976	1970-03 to 1973-05 	Non-randomized, fewer than 20 pts
Note: POMP is still used in maintenance settings; this is marked historic because it is late intensification.
====Chemotherapy====
*Mercaptopurine (6-MP) 500 mg/m2 IV once per day on days 1 to 5
*Vincristine (Oncovin) 2 mg IV once on day 1
*Methotrexate (MTX) 7.5 mg/m2 IV once per day on days 1 to 5
====Glucocorticoid therapy====
*Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
One course
===References===
# Bodey GP, Freireich EJ, Gehan E, McCredie KB, Rodriguez V, Gutterman J, Burgess MA. Late intensification therapy for acute leukemia in remission: chemotherapy and immunotherapy. JAMA. 1976 Mar 8;235(10):1021-5. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
=Relapsed or refractory=
==BCG vaccine monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence
Mathé et al. 1969	Not reported 	Non-randomized
====Immunotherapy====
*BCG vaccine
===References===
# Mathé G, Amiel JL, Schwarzenberg L, Schneider M, Cattan A, Schlumberger JR, Hayat M, De Vassal F. Active immunotherapy for acute lymphoblastic leukaemia. Lancet. 1969 Apr 5;1(7597):697-9. link to original article EuroPMC
==Pentostatin monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence
Prentice et al. 1981	Not reported 	Pilot
====Chemotherapy====
*Pentostatin (Nipent) 0.15 to 0.5 mg/kg IV bolus once per day
5- to 7-day course
===References===
# Prentice HG, Russell NH, Lee N, Ganeshaguru K, Blacklock H, Piga A, Smyth JF, Hoffbrand AV. Therapeutic selectivity of and predication of response to 2'-deoxycoformycin in acute leukaemia. Lancet. 1981 Dec 5;2(8258):1250-4. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
==TBI, then auto HSCT==
TBI: Total Body Irradiation
===Regimen===
Study 	Evidence
McGovern et al. 1959	Pilot
Note: This is of historic interest and likely the first reported use of autologous HSCT in the treatment of malignancy.
===References===
# McGovern JJ Jr, Russell PS, Atkins L, Webster EW. Treatment of terminal leukemic relapse by total-body irradiation and intravenous infusion of stored autologous bone marrow obtained during remission. N Engl J Med. 1959 Apr 2;260(14):675-83. link to original article EuroPMC
==Vincristine liposomal monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Efficacy
O'Brien et al. 2012 (RALLY)	2007 to not reported	Phase 2 (RT)	ORR: 35%
====Chemotherapy====
*Vincristine liposomal (Marqibo) 2.25 mg/m2 IV over 60 minutes once on day 1
7-day cycles
===References===
# RALLY: O'Brien S, Schiller G, Lister J, Damon L, Goldberg S, Aulitzky W, Ben-Yehuda D, Stock W, Coutre S, Douer D, Heffner LT, Larson M, Seiter K, Smith S, Assouline S, Kuriakose P, Maness L, Nagler A, Rowe J, Schaich M, Shpilberg O, Yee K, Schmieder G, Silverman JA, Thomas D, Deitcher SR, Kantarjian H. High-dose vincristine sulfate liposome injection for advanced, relapsed, and refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia. J Clin Oncol. 2013 Feb 20;31(6):676-83. Epub 2012 Nov 19. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT00495079
Category:B-cell acute lymphoblastic leukemia regimens
Category:Historical regimens
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Category:Acute lymphoblastic leukemias
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